Rehabilitation Robotic System ReHand

Sponsor
Karaganda Medical University
Study ID
NCT06937346
Status
Completed

Conditions

  • Rehabilitation
  • Robotic Exoskeleton
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jul 2025
Primary completion
May 30, 2025
Completion
May 30, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [ Time Frame: 60 days later ]

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