Status:
UNKNOWN
Digital Interactive Technologies in Rehabilitation of Post-sroke Patients With Impaired Fine Function of the Hand
Lead Sponsor:
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Conditions:
Stroke Rehabilitation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of the study is to investigate the efficacy and safety of digital interactive technology with artificial intelligence and biofeedback Smart glove "SensoRehab" for restoration of in-hand manipu...
Detailed Description
The study is an open-label observational trial. Brain stroke (BS) is one of the main causes of upper limb (UL) dysfunction and limitations of daily human activity.The fine use of the hand imparement i...
Eligibility Criteria
Inclusion
- Men or women aged 18 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
- Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
- Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
- Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
- The patient's ability and willingness to comply with the requirements of this protocol.
Exclusion
- Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
- Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
- Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
- Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
- Sensory aphasia, gross motor aphasia.
- Recurrent stroke.
- Unstable angina and/or heart attack in previous month.
- Uncontrolled arterial hypertension.
- Somatic diseases in decompensation stage.
- Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
- Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
- Pregnancy.
- Lactation.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05214521
Start Date
January 11 2021
End Date
December 30 2023
Last Update
May 17 2022
Active Locations (1)
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1
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, Russia, 105120