REHABILITATION ROBOTIC SYSTEM REHAND

Not Applicable

Active, not recruiting

• Conditions: Stroke; Rehabilitation; Robotic Exoskeleton

• Registration Number: NCT06937346
• Lead Sponsor: Karaganda Medical University

Brief Summary

The aim of this clinical trial is to investigate the efficacy of the ReHand rehabilitation system for the recovery of patients after a stroke.

The main objectives of the study:

1. To assess the functional state of patients with cerebral stroke according to the The Barthel Index, on the Functional Independence Measure (FIM) scale of functional independence.

2. To assess the neurological deficit of patients according to the National Institutes of Health Stroke Scale (NIHSS), the state of function of the affected arm and the degree of fine motor impairment according to the The Frenchay Arm Test (FAM), The Fugl-Meyer Assessment for upper extremity (FMA-UE) scale, Wolf Motor Function Test (WMFT), according to the upper limb disability questionnaire The Disabilities of the Arm, Shoulder, and Hand (DASH) test.

3. To investigate the state of psycho-emotional status in patients on the Hospital Anxiety and Depression Scale (HADS) of anxiety and depression.

4. To determine the effectiveness of the rehabilitation performed in patients with cerebral stroke after recovery by the ReHand system according to the above scales.

Participants:

All patients received standard rehabilitation methods according to the clinical protocol for diagnosis and treatment No. 94, "The third stage of medical rehabilitation", approved by the Joint Commission on the Quality of Medical Services of the Ministry of Health of the Republic of Kazakhstan on May 14, 2020.

The main group of patients underwent rehabilitation using a robotic glove for 6 weeks, with 5 classes per week and each class lasting 30 minutes.

The control group did not receive robotic glove-based rehabilitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-05-30
• Study First Submitted: 2025-03-29
• Status Verified: 2025-04
• Study Completion: 2025-04-15
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• a stroke that occurred no more than six months prior;
• absence of somatic conditions that would interfere with the use of the hand exoskeleton system (such as rheumatoid arthritis, severe muscle hypertonia, joint pathology, fractures, etc.);
• clear consciousness;
• presence of upper limb and fine motor impairments;
• no history of recurrent cerebral strokes;
• no comorbidities associated with cognitive dysfunction (such as Parkinson's disease, Wernicke's encephalopathy, alcoholic encephalopathy, etc.) that would hinder instruction comprehension;
• absence of rheumatological issues (including contractures and significant pain syndromes) that would impede study participation;
• absence of acute or chronic (in the decompensated stage) diseases of internal organs;
• signing of informed consent for study participation;
• all participants were adults

Exclusion criteria:

• lack of clear consciousness,
• a history of recurrent cerebral stroke,
• a stroke that occurred more than 6 months ago,
• lack of upper limb function or fine motor disorders,
• the presence of concomitant diseases associated with cognitive dysfunction (such as Parkinson's disease, Wernicke encephalopathy, alcoholic encephalopathy, etc.) that may interfere with understanding the instructions,
• rheumatological diseases.
• problems (including contractures and severe pain syndromes) that could interfere with participation in the study,
• the presence of acute or chronic (decompensation stage) diseases of internal organs,
• contraindications according to Clinical Protocol No. 94 on diagnosis and treatment "The third stage of medical rehabilitation", approved by the Ministry of Health of the Republic of Kazakhstan on May 14, 2020 (frequent or severe bleeding of various origins; febrile or subfebrile fever of unknown origin; acute infectious diseases; acute osteomyelitis; acute deep vein thrombosis; complicated cardiac arrhythmias, heart failure in the active stage; active forms of tuberculosis; malignant tumors (IV clinical group).; respiratory failure of stage III and above; various purulent (pulmonary) diseases with significant intoxication; decompensated diseases such as irreversible metabolic disorders (diabetes mellitus, myxedema, thyrotoxicosis, etc.), functional insufficiency of the liver or pancreas of stage III; epilepsy in the seizure phase; mental disorders causing desocialization and emotional or behavioral disorders.; purulent skin diseases, infectious skin diseases (scabies, fungal infections, etc.); anemia with an Hb level of 90 g/l or lower; lack of signed informed consent to participate in the study.; and the underage age of the participants).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer Assessment for upper extremity (FMA-UE)	Before the start of treatment and 60 days later,	Score gradation: 0-1-2, where 0 = cannot perform, 1 = partially performs, and 2 = performs completely. The maximum number of points is 66 (shoulder and forearm - 36, wrist and hand - 30 points). The higher the score, the better the outcome.The minimum clinically significant improvement is 5.25 points.

Secondary Outcome Measures

Name	Time	Method
The Barthel Index (BI)	Before the start of treatment and 60 days later	The Barthel Index score ranges from 0 to 100, with a higher score indicating less dependence in everyday life.
Functional Independence Measure scale (FIM)	Before the start of treatment and 60 days later	The FIM scale score can range from 18 to 126 points, with a lower score indicating greater dependence on others in daily activities.
The Frenchay Arm Test	Before the start of treatment and 60 days later	The Frenchay Arm Test score ranges from 0 to 6 points, where a higher score indicates better hand function.
National Institutes of Health Stroke Scale (NIHSS)	Before the start of treatment and 60 days later	The NIHSS scale for neurological examination ranges from 0 to 42 points, with higher scores indicating more severe symptoms.
Wolf Motor Function Test (WMFT)	Before the start of treatment and 60 days later	The Wolf Motor Function Test has a maximum score of 75 points, with lower scores indicating lower levels of function.
The Disabilities of the Arm Shoulder, and Hand (DASH) test	Before the start of treatment and 60 days later	The Disabilities of the Arm, Shoulder, and Hand (DASH) test has a total score of 100 points, with higher scores indicating more disability.
Hospital Anxiety and Depression Scale (HADS)	Before the start of treatment and 60 days later	The Hospital Anxiety and Depression Scale has an overall score of up to 42 points, with higher scores indicating clinically significant anxiety or depression.

Trial Locations

Locations (1)

Karaganda region; 🇰🇿 Karaganda, Kazakhstan