Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

Not Applicable

• Conditions: Cerebrovascular Accident
• Interventions: Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke

• Registration Number: NCT04028999
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

Detailed Description

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Pain associated with UL impairment due to multifactorial causes is a frequent symptom in patients with stroke. Occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (SD) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. At present, positioning principles of the hemiplegic shoulder exist in clinical practice. These are aimed at prevention of pain associated with UL Impairment; however there is no clear consensus among professionals of particular SD that should be implemented for adults with stroke

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Having suffered in the last 6 months maximum a first stroke responsible for hemiplegia.
• Finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf.
• Boston Diagnostic Aphasia Examination (BDAE) > 3.
• Consent of the patient
• Patient affiliated or benefiting from a social security scheme

Exclusion Criteria

• Stroke recurrence, or stroke more than 6 months-old
• Patient already wearing a coaptation scarf
• Presence of lymphoedema, venous thrombosis of the upper limb
• Neoprene allergy
• Severe cognitive impairment: Mini-Mental State (MMS) <15
• Patient being part of another care protocol
• Adult under the protection of justice, tutors or curators
• Pregnant or lactating woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the EO31 shoulder sling	Evaluate the effects of the EO31 shoulder sling in adults post-stoke	To develop and evaluate the effects of the EO31 shoulder sling for the prevention of pain, subluxation, spasticity, as well as effect on increasing functional use of the UL in activities of daily living.

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale	5 weeks	GAS (Goal Attainment Scale) scores will be described with regards to the 3 client-centred objectives. The score for each objective is comprised between -2 (when objective is not achieve) to 2 (achieve objective).

Secondary Outcome Measures

Name	Time	Method
Number of daily use of the upper limb sling	5 weeks	Evaluate if patient use the sling : number of use by day
motor function of upper limb with CAHAI scale	5 weeks	the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)	24 hours	The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain)
Evaluate shoulder pain with EVA scale	baseline	The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).
motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale	baseline	the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
questionnaire for quality of patient's life	5 weeks	the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)
Spasticity with TARDIEU scale	5 weeks	Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Clinical measure of appendage	5 weeks	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, France