Rehabilitation, Robotic Exoskeleton, Stroke
Conditions
Keywords
Exoskeleton of the hand, rehabilitation, robotic system, recovery, cerebral stroke
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 (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. 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 8 weeks, with 5 classes per week and each class lasting 45 minutes. The control group did not receive robotic glove-based rehabilitation.
Interventions
DEVICEThe 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.
OTHERStandard 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.
Sponsors
Karaganda Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.; * he underage age of the participants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 60 days later | Fugl-Meyer Assessment for Upper Extremity (FMA-UE); range: 0-66 points; higher scores indicate better motor function and less impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure Scale (FIM) | 60 days later | Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence. |
| National Institutes of Health Stroke Scale (NIHSS) | 60 days later | National Institutes of Health Stroke Scale (NIHSS); range: 0-42 points; higher scores indicate more severe neurological impairment. |
| Frenchay Arm Test | 60 days later | Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function. |
| Barthel Index (BI) | 60 days later | Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living. |
| Disabilities of the Arm Shoulder, and Hand (DASH) Test | 60 days later | Disabilities of the Arm, Shoulder and Hand (DASH); range: 0-100 points; higher scores indicate greater disability. |
| Hospital Anxiety and Depression Scale (HADS) | 60 days later | Hospital Anxiety and Depression Scale (HADS); range: 0-42 points; higher scores indicate greater psychological distress (more severe anxiety and depression symptoms). |
| Modified Wolf Motor Function Test (mWMFT) | 60 days later | modified Wolf Motor Function Test (mWMFT); total score range: 0-75 points; higher scores indicate better upper extremity motor function. |
Countries
Kazakhstan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Control Group: Standard Rehabilitation Only | Total | Intervention Group: Robot Rehand + Standard Rehabilitation |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 10 | 59.5 years STANDARD_DEVIATION 9.5 | 59.7 years STANDARD_DEVIATION 9 |
| Barthel Index (BI) | 45.0 score on a scale | 40.0 score on a scale | 40.0 score on a scale |
| Days after stroke | 106.0 days STANDARD_DEVIATION 46.7 | 105.1 days STANDARD_DEVIATION 45.6 | 104.2 days STANDARD_DEVIATION 45 |
| Disabilities of the Arm, Shoulder and Hand (DASH) | 46.5 score on a scale | 46.0 score on a scale | 46.0 score on a scale |
| Frenchay Arm Test (FAT) | 1.0 score on a scale | 1.0 score on a scale | 1.0 score on a scale |
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 29.0 score on a scale | 29.0 score on a scale | 29.0 score on a scale |
| Functional Independence Measure (FIM) | 54.5 score on a scale | 54.0 score on a scale | 52.0 score on a scale |
| Hospital Anxiety and Depression Scale (HADS) | 31.0 score on a scale | 30.0 score on a scale | 28.0 score on a scale |
| modified Wolf Motor Function Test (mWMFT) | 37.0 score on a scale | 36.5 score on a scale | 36.0 score on a scale |
| National Institutes of Health Stroke Scale(NIHSS) | 8.0 score on a scale | 8.0 score on a scale | 8.0 score on a scale |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Male | 44 Participants | 90 Participants | 46 Participants |
| Type of stroke Hemorrhagic | 15 Participants | 31 Participants | 16 Participants |
| Type of stroke Ischemic | 45 Participants | 89 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 1 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: 60 days later
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 45.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 36.0 score on a scale |
Secondary
Barthel Index (BI)
Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living.
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Barthel Index (BI) | 70.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Barthel Index (BI) | 55.0 score on a scale |
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.
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Disabilities of the Arm Shoulder, and Hand (DASH) Test | 17.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Disabilities of the Arm Shoulder, and Hand (DASH) Test | 39.0 score on a scale |
Secondary
Frenchay Arm Test
Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function.
Time frame: 60 days later
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Frenchay Arm Test | 3.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Frenchay Arm Test | 2.0 score on a scale |
Secondary
Functional Independence Measure Scale (FIM)
Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence.
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Functional Independence Measure Scale (FIM) | 76.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Functional Independence Measure Scale (FIM) | 61.0 score on a scale |
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).
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Hospital Anxiety and Depression Scale (HADS) | 16.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Hospital Anxiety and Depression Scale (HADS) | 22.5 score on a scale |
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.
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | Modified Wolf Motor Function Test (mWMFT) | 53.0 score on a scale |
| Control Group: Standard Rehabilitation Only | Modified Wolf Motor Function Test (mWMFT) | 44.0 score on a scale |
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.
Time frame: 60 days later
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group: Robot Rehand + Standard Rehabilitation | National Institutes of Health Stroke Scale (NIHSS) | 4.0 score on a scale |
| Control Group: Standard Rehabilitation Only | National Institutes of Health Stroke Scale (NIHSS) | 6.5 score on a scale |