Digital Interactive Technologies in Rehabilitation of Post-sroke Patients With Impaired Fine Function of the Hand

NCT05214521 | Unknown

• 1 other identifier: 9 12112020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 manipulation in patients with ischemic stroke in the early and late recovery periods.

Conditions

Stroke Rehabilitation

Keywords

post-stroke dysfunction of the hand; upper limb medical rehabilitation; digital interactive technology; artificial intelligence; ischemic stroke rehabilitation

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic

  The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy.

  Baseline, end of the 2-nd week

• Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic

  The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy.

  Baseline, 1-month after completing training

• Action Research Arm Test (ARAT) Scale dynamic

  The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy.

  Baseline, end of the 2-nd week

• Action Research Arm Test (ARAT) Scale dynamic

  The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy.

  Baseline, 1-month after completing training

Secondary Outcomes (7)

• percentage of correctly performed tasks

  Baseline, end of the 2-nd week

• change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS

  Baseline, end of the 2-nd week and 1-month after completing training

• changes in spasticity severity

  Baseline, end of the 2-nd week and 1-month after completing training

• changes in level of impairment or dependence in daily life

  Baseline, end of the 2-nd week and 1-month after completing training

• сhanges in cognitive status

  Baseline, end of the 2-nd week and 1-month after completing training

Study Arms (1)

digital interactive technology Smart glove "SensoRehab"

EXPERIMENTAL

The operation of the digital interactive complex Smart glove "SensoRehab" is based on the visual and kinesthetic (proprioceptive) biofeedback principle by using a set of cognitive interactive computer games controlled by finger and hand movements. The technique involves neurosensory training and retraining to improve the fine use of the hand and arm, and the patient's cognitive and emotional state.

Device: digital interactive technology Smart glove "SensoRehab"

Interventions

digital interactive technology Smart glove "SensoRehab" DEVICE

Participants will receive rehabilitation program including sessions on the Smart glove "SensoRehab" (SGSR) system. The program for IS patients includes 10 sessions with the SGSR: 15-30 minutes once a day for the affected hand, 2 weeks.

digital interactive technology Smart glove "SensoRehab"

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
• Pregnancy.
• Lactation.

Sponsors & Collaborators

• Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine: lead

Study Sites (1)

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7

Moscow, 105120, Russia

RECRUITING

Study Officials

• Elena V Kostenko, MD

  Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liudmila V Petrova, PhD

CONTACT

+79163940742; ludmila.v.petrova@yandex.ru

Elena V Kostenko, MD

CONTACT

+79057685856; ekostenko58@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: an open-label observational trial

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: January 11, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

RU (1)