Clinical trial NCT06937346: REHABILITATION ROBOTIC SYSTEM REHAND
Official title: TO STUDY THE EFFECTIVENESS OF RECOVERY IN PATIENTS WITH CEREBRAL STROKE THROUGH THE USE OF THE REHAND REHABILITATION SYSTEM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Rehabilitation
Robotic Exoskeleton
Keywords: Exoskeleton of the hand
rehabilitation
robotic system
recovery
cerebral stroke
Lead sponsor: Karaganda Medical University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: Before the start of treatment and 60 days later,
Secondary outcomes:
measure: The Barthel Index (BI)
timeFrame: Before the start of treatment and 60 days later
measure: Functional Independence Measure scale (FIM)
timeFrame: Before the start of treatment and 60 days later
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Before the start of treatment and 60 days later
measure: The Frenchay Arm Test
timeFrame: Before the start of treatment and 60 days later
measure: Wolf Motor Function Test (WMFT)
timeFrame: Before the start of treatment and 60 days later
measure: The Disabilities of the Arm Shoulder, and Hand (DASH) test
timeFrame: Before the start of treatment and 60 days later
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before the start of treatment and 60 days later
Other outcomes:
Locations:
city: Karaganda
country: Kazakhstan
facility: Karaganda region
Study officials:
References: