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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
Karaganda region
Karaganda, Kazakhstan
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
Barthel Index (BI)
Barthel Index; range: 0-100 points; higher scores indicate greater independence in activities of daily living.
Time frame: 60 days later
Functional Independence Measure Scale (FIM)
Functional Independence Measure (FIM); range: 18-126 points; higher scores indicate greater functional independence.
Time frame: 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.
Time frame: 60 days later
Frenchay Arm Test
Frenchay Arm Test (FAT); range: 0-5 points; higher scores indicate better arm function.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 60 days later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.