Rehabilitation Robotic System ReHand

NCT06937346 | Completed Results

• 1 other identifier: 3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 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. 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 (FAT), The Fugl-Meyer Assessment for upper extremity (FMA-UE) scale, modified Wolf Motor Function Test (mWMFT), according to the upper limb disability questionnaire The Disabilities of the Arm, Shoulder, and Hand (DASH) test.
3. 3.To investigate the state of psycho-emotional status in patients on the Hospital Anxiety and Depression Scale (HADS) of anxiety and depression.
4. 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.

Conditions

Stroke; Rehabilitation; Robotic Exoskeleton

Keywords

Exoskeleton of the hand; rehabilitation; robotic system; recovery; cerebral stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Fugl-Meyer Assessment for Upper Extremity (FMA-UE); range: 0-66 points; higher scores indicate better motor function and less impairment.

  60 days later

Secondary Outcomes (7)

• Barthel Index (BI)

  60 days later

• Functional Independence Measure Scale (FIM)

  60 days later

• National Institutes of Health Stroke Scale (NIHSS)

  60 days later

• Frenchay Arm Test

  60 days later

• Modified Wolf Motor Function Test (mWMFT)

  60 days later

Study Arms (2)

intervention group: Robot Rehand + Standard Rehabilitation

EXPERIMENTAL

The patients in the main group will undergo standard rehabilitation combined with the use of the ReHand robotic device, five times per week for 60 days.

Device: The Rehand Robotic Glove; Other: Standard Rehabilitation

Control group: Standard Rehabilitation Only

ACTIVE COMPARATOR

Patients in the control group will undergo standard rehabilitation, without the use of the ReHand robotic device. They will attend sessions 5 times per week for 60 days.

Other: Standard Rehabilitation

Interventions

The Rehand Robotic Glove DEVICE

The exoskeleton hand system provides recovery and training for paralyzed fingers using an innovative method that mirrors the movements of a healthy hand. The system uses a sensor glove to read movements and transfer them to a rehabilitation glove. This forces the injured hand to repeat the same movements as the healthy hand, helping to restore motor skills. The system combines flexible robotics with neuroscience to help patients retrain their muscles. It reduces muscle tension and swelling, relieves stiffness, improves blood circulation, and restores muscle performance after atrophy. It also reduces hypertension and joint pain, and activates neuroplasticity through passive and active techniques. All patients received standard rehabilitation treatments in accordance with clinical protocol No. 94 for the third stage of medical rehabilitation, approved by the Joint Commission on Quality of Medical Services from the Ministry of Health of Kazakhstan on 14 May 2020.

intervention group: Robot Rehand + Standard Rehabilitation

Standard Rehabilitation OTHER

All patients received standard rehabilitation treatments in accordance with clinical protocol No. 94 for the third stage of medical rehabilitation, approved by the Joint Commission on Quality of Medical Services from the Ministry of Health of Kazakhstan on 14 May 2020.

Control group: Standard Rehabilitation Only; intervention group: Robot Rehand + Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.;
• he underage age of the participants.

Sponsors & Collaborators

• Karaganda Medical University: lead

Study Sites (1)

Karaganda region

Karaganda, 100008, Kazakhstan

Location

Related Publications (1)

• Amirbekova M, Kispayeva T, Izbassarova A, Adomaviciene A, Sorokina M, Zhunussova T. Rehabilitation of patients in the subacute phase of stroke using the ReHand robotic system: a randomized controlled trial. Front Hum Neurosci. 2025 Nov 24;19:1690643. doi: 10.3389/fnhum.2025.1690643. eCollection 2025.

  PMID: 41377192 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amirbekova Mariyam Sayatovna
• Organization: Karaganda Medical University

Amirbekova31081998@gmail.com

+77472224951

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 22, 2025
• Study Start: March 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)