Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers

• Registration Number: NCT06312631
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

On a functional level, performing the actions of daily life requires coordinated activity of the muscles of the upper limbs. The quality of motor recovery and/or technical assistance aimed at compensating for the movement deficit of the paretic upper limb (MSP) determines the possibilities of using the upper limb (MS) in activities of daily life.

Interventions in the chronic phase of stroke aim to return home. The integration of the paretic upper limb into daily life activities is a major issue regarding the prognosis of recovery of use of the upper limb. Independence in daily life becomes an ultimate goal to take charge of.

Our study focuses on a new technical aid device, standard orthosis type, expanding the range of gripping gloves: the SaeboGlove in everyday environments. These MS orthoses help improve the use and function of the MSP in post-stroke adults as well as their independence and participation in society.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Study Start: 2024-04-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient suffering from a motor deficit of the upper limb resulting from an ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging ;
• Patient who suffered a stroke more than three months ago;
• Patient unable to actively extend long fingers (hand opening) to voluntarily grasp an empty glass (upper and lower diameter of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125g, identical to equipment used for ARAT), with a palmar grip (cylindrical grip), while the subject can hold the previously placed glass passively in the hand;
• Patient capable of passively opening the hand sufficient to grasp the glass when the gripping glove is put on, with the possibility of actively closing the hand;
• Patient with the ability to put on and remove the SaeboGlove® gripping glove with the help of a third person if necessary and/or available.
• Patient with a smartphone, tablet and/or computer compatible with video taking and teleconsultation.
• Free, informed and signed consent by the participant and/or the person having guardianship and the investigator (at the latest on the day of inclusion and before any examination required by the research);
• Person affiliated to or beneficiary of a social security system.

Exclusion Criteria

• Patient presenting retraction or stiffness of the fingers and wrist preventing complete extension of the long fingers and thumb, the wrist being at 15° extension;
• Patient with moderate or severe muscular spasticity of the wrist flexors and the long and short flexors of the fingers and thumb (Modified Ashworth Scale ≥ 3);
• Patient with limited active elbow extension, not allowing the ipsilateral knee to be reached with the hand, the subject being seated with the trunk vertical (approach limitation);
• Patient with an active anterior shoulder elevation range of less than 15°;
• Patient with other upper limb deficiencies likely to influence participation;
• Patient and/or entourage who do not have access to teleconsultation, and/or can be reached remotely;
• Patient with severe aphasia, Boston Diagnostic Aphasia Examination (BDAE) ≤ 3;
• Presence of moderate or severe edema localized to the wrist and hand;
• Patient allergic to Latex
• History of upper limb surgery less than 6 months old.
• Pregnant and/or breastfeeding women
• Patient deprived of liberty (detained/incarcerated);
• Patient under judicial protection
• Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Task handover model #1	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #3	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #1	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #2	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #1	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #1	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #2	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #3	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #2	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #2	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #3	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #4	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #3	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #4	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #5	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #3	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #4	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #5	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #5	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #4	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #5	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #5	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #6	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #7	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #5	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #5	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #5	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #6	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #7	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Motor Activity Log (MAL) Questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #5	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #5	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #6	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #7	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #6	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #6	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #7	Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	Score Action Arm Research Test	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	ULPA questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Putting on the gripping glove	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Psychosocial Impact of Assistive Devices Scale (PIADS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #7	installation and collection of accelerometers	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Quebec User Evaluation of Satisfaction with Assistive Technology	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	EuroQol five-level (EQ-5D-5L) questionnaire	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Goal Attainment Scale (GAS)	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA

Primary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of the gripping glove	6 months	The evaluation of the effectiveness of the gripping glove on the performance of the upper limb in daily life will be evaluated using the ULPA score and compared between the 2 conditions (with and without the glove) in the performance of a daily activity.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the performance of an activity in the real context of the patient	6 months	The performance of an activity in the real context of the patient will be evaluated using the GAS. Information is collected from the person and/or their entourage at each visit, assessed during visits T1 (14 days), T2 (3 months) and T3 (6 months) by the assessor (occupational therapist) from each center.
Evaluation of factual spontaneous use of the upper limb in daily life	6 months	Factual spontaneous use of the upper limb in daily life will be measured using a wrist accelerometer. The movement will be compared between T0, T2 (3 months) and T3 (6 months).
Assessment of the quality of voluntary motor skills of the upper limb	6 months	The quality of voluntary motor skills of the upper limb will be assessed with the FMA at T0, T2 (3 months) and T3 (6 months), without wearing the gripping glove.
Evaluation of the perceived performance of the use of the paretic upper limb	6 months	The perceived performance of the use of the paretic upper limb will be evaluated using the MAL at T0, T2 (3 months) and T3 (6 months).
Assessment of gripping abilities	6 months	Grasping abilities will be assessed by the ARAT at T0, T2 (3 months) and T3 (6 months), without wearing the gripping glove.
Quality of life assessment	6 months	Quality of life, assessed using the EQ-5D-5L, will be explored at T0, T2 (3 months) and T3 (6 months).
Evaluation of satisfaction and tolerance	6 months	Satisfaction and tolerance will be assessed by the patient with the QUEST version 2.0 questionnaire, at the end of the T3 visit (6 months).
Evaluation of the psycho-social impact	6 months	The psycho-social impact will be assessed with the F-PIADS questionnaire during visits to T2 (3 months) T3 (6 months), by the evaluator (occupational therapist) from each center.

Trial Locations

Locations (1)

Claire VILLEPINTE; 🇫🇷 Toulouse, France