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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index (BI) | Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living. | 60 days later |
| Functional Independence Measure Scale (FIM) | Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence. |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaganda region | Karaganda | 100008 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41377192 | Derived | 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. |
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A total of 120 participants provided informed consent and were enrolled in the study. All enrolled participants were randomized into two groups, with 60 participants in each group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group: Robot Rehand + Standard Rehabilitation | 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. The Rehand Robotic Glove: 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 Rehabilitation: 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. |
| FG001 | Control Group: Standard Rehabilitation Only | 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. Standard Rehabilitation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group: Robot Rehand + Standard Rehabilitation | 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. The Rehand Robotic Glove: 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 Rehabilitation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
From the first treatment session through the end of the 60-day intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group: Robot Rehand + Standard Rehabilitation | 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. The Rehand Robotic Glove: 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 Rehabilitation: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amirbekova Mariyam Sayatovna | Karaganda Medical University | +77472224951 | Amirbekova31081998@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2024 | Jun 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
| 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. | 60 days later |
| Frenchay Arm Test | Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function. | 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. | 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. | 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). | 60 days later |
| BG001 | Control Group: Standard Rehabilitation Only | 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. Standard Rehabilitation: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type of stroke | Count of Participants | Participants |
|
| Days after stroke | Mean | Standard Deviation | days |
|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Fugl-Meyer Assessment for Upper Extremity; range: 0-66 points; higher scores indicate better motor function and less impairment. | Median | Inter-Quartile Range | score on a scale |
|
| Barthel Index (BI) | Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living. | Median | Inter-Quartile Range | score on a scale |
|
| 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. | Median | Inter-Quartile Range | score on a scale |
|
| Functional Independence Measure (FIM) | Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence. | Median | Inter-Quartile Range | score on a scale |
|
| Frenchay Arm Test (FAT) | Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function. | Median | Inter-Quartile Range | score on a scale |
|
| 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. | Median | Inter-Quartile Range | score on a scale |
|
| Disabilities of the Arm, Shoulder and Hand (DASH) | Disabilities of the Arm, Shoulder and Hand (DASH); range: 0-100 points; higher scores indicate greater disability. | Median | Inter-Quartile Range | score on a scale |
|
| 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). | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | Control Group: Standard Rehabilitation Only | 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. Standard Rehabilitation: 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. |
|
|
| Secondary | Barthel Index (BI) | Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | Functional Independence Measure Scale (FIM) | Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | Frenchay Arm Test | Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function. | Posted | Mean | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 60 days later |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Control Group: Standard Rehabilitation Only | 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. Standard Rehabilitation: 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. | 0 | 60 | 0 | 60 | 1 | 60 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |