Status:
COMPLETED
Rehabilitation Robotic System ReHand
Lead Sponsor:
Karaganda Medical University
Conditions:
Stroke
Rehabilitation
Eligibility:
All Genders
18-74 years
Phase:
NA
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 func...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06937346
Start Date
March 1 2024
End Date
May 30 2025
Last Update
August 5 2025
Active Locations (1)
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1
Karaganda region
Karaganda, Kazakhstan, 100008