StrokeNCT06937346

Rehabilitation Robotic System ReHand

A study testing The Rehand Robotic Glove and Standard Rehabilitation in people with Stroke and Rehabilitation, run by Karaganda Medical University at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Stroke, Rehabilitation, Robotic Exoskeleton
What is being tested?: The Rehand Robotic Glove and Standard Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteKazakhstan
Study dates: 1 Mar 2024to 30 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Karaganda region
Karaganda, 100008

Other trials in Kazakhstan

About this study

Official title: Robotic-Assisted Upper Limb Rehabilitation After Stroke Using the ReHand System: A Randomized Controlled Trial

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:

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.
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.
To investigate the state of psycho-emotional status in patients on the Hospital Anxiety and Depression Scale (HADS) of anxiety and depression.
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 8 weeks, with 5 classes per week and each class lasting 45 minutes.

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

Conditions: Stroke, Rehabilitation, Robotic Exoskeleton
Being tested: The Rehand Robotic Glove, Standard Rehabilitation
Keywords: Exoskeleton of the hand, rehabilitation, robotic system, recovery, cerebral stroke
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Rehand Robotic GloveDevice
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.
Standard RehabilitationOther
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.

Study groups in NCT06937346
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Standard Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 days later

Secondary outcomes (7)

Barthel Index (BI)
Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living.
Measured: 60 days later
Functional Independence Measure Scale (FIM)
Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence.
Measured: 60 days later
National Institutes of Health Stroke Scale (NIHSS)
National Institutes of Health Stroke Scale (NIHSS); range: 0-42 points; higher scores indicate more severe neurological impairment.
Measured: 60 days later
Frenchay Arm Test
Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function.
Measured: 60 days later
Modified Wolf Motor Function Test (mWMFT)
modified Wolf Motor Function Test (mWMFT); total score range: 0-75 points; higher scores indicate better upper extremity motor function.
Measured: 60 days later
Disabilities of the Arm Shoulder, and Hand (DASH) Test
Disabilities of the Arm, Shoulder and Hand (DASH); range: 0-100 points; higher scores indicate greater disability.
Measured: 60 days later
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS); range: 0-42 points; higher scores indicate greater psychological distress (more severe anxiety and depression symptoms).
Measured: 60 days later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202430 May 2025

First posted22 Apr 2025
Study start1 Mar 2024
Primary completion30 May 2025
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06937346
Sponsor's protocol ID: 3
Status last verified: Jul 2025
First submitted: 29 Mar 2025
Last updated: 5 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41377192

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robotic-Assisted Upper Limb Rehabilitation After Stroke Using the ReHand System: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06937346
Acronym / sponsor ID: 3
Conditions: Stroke, Rehabilitation, Robotic Exoskeleton
Keywords: Exoskeleton of the hand, rehabilitation, robotic system, recovery, cerebral stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Karaganda Medical UniversityUniversity, hospital or other
Study start: 1 Mar 2024 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 May 2025 (actual)
First posted: 22 Apr 2025 (actual)
Results: Posted 5 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

The main group of patients underwent rehabilitation using a robotic glove for 8 weeks, with 5 classes per week and each class lasting 45 minutes.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
intervention group: Robot Rehand + Standard Rehabilitation	Experimental	Device: The Rehand Robotic Glove, Other: Standard RehabilitationThe 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.
Control group: Standard Rehabilitation Only	Active comparator	Other: Standard RehabilitationPatients 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.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (11 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Rehand Robotic GloveThe 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.	Device	intervention group: Robot Rehand + Standard Rehabilitation
Standard RehabilitationAll 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.	Other	Control group: Standard Rehabilitation Only, intervention group: Robot Rehand + Standard Rehabilitation

Primary outcome

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: 60 days later
Fugl-Meyer Assessment for Upper Extremity (FMA-UE); range: 0-66 points; higher scores indicate better motor function and less impairment.

7 secondary outcomes

Barthel Index (BI)
Time frame: 60 days later
Functional Independence Measure Scale (FIM)
Time frame: 60 days later
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 60 days later
Frenchay Arm Test
Time frame: 60 days later
Modified Wolf Motor Function Test (mWMFT)
Time frame: 60 days later
Disabilities of the Arm Shoulder, and Hand (DASH) Test
Time frame: 60 days later
Hospital Anxiety and Depression Scale (HADS)
Time frame: 60 days later

Results and safety

Results posted to the registry on 5 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group: Robot Rehand + Standard Rehabilitation	60	60
Control Group: Standard Rehabilitation Only	60	60

Primary outcome: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Time frame: 60 days later. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intervention Group: Robot Rehand + Standard Rehabilitation n = 60	Control Group: Standard Rehabilitation Only n = 60
Value	45.0 (42.0 to 49.0)	36.0 (33.0 to 38.2)

Population analysed: All randomized participants completed the treatment and were included in the analysis. There were no dropouts or missing outcome data. The analysis was conducted on the full population according to the intention-to-treat principle.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first treatment session through the end of the 60-day intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group: Robot Rehand + Standard Rehabilitation	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Control Group: Standard Rehabilitation Only	0 of 60 (0%)	1 of 60 (1.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41377192Amirbekova 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Rehand Robotic Glove and Standard Rehabilitation in people with Stroke and Rehabilitation, run by Karaganda Medical University at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: 60 days later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06937346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.