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

Investigation of the Effectiveness and Safety of Rehabilitation of Patients With Impaired Fine Function of the Hand Due to a Stroke Using "Glove Simulator "SensoRehab" Based on Digital Interactive Technologies With Artificial Intelligence

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Rehabilitation
• Intervention / Treatment: Device: digital interactive technology Smart glove "SensoRehab"

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 is often combined with speech, cognitive and emotional disturbances, which is due to the anatomical proximity and close functional relationships of the corresponding areas in the cerebral cortex.

The objective of the present study will be to evaluate the effectiveness and safety of the digital interactive technology (DIT) with artificial intelligence and biofeedback Smart glove "SensoRehab" (SGSR) for restoration of in-hand manipulation in patients with ischemic stroke in the early and late recovery period.The SGSR technique involves neurosensory training and retraining to improve the fine use of the hand and arm, and the patient's cognitive and emotional state.

30 patients will be include to the study. After a basic assessment of hand motor function and game training, each patient undergoes sessions on the SGSR system. The program for BS patients includes 10 sessions with the SGSR (15-30 minutes once a day for the affected hand, 2 weeks).

The clinical outcomes will be obtained at the completion of treatment (2 weeks) and at 1 month after ompletion of the course of rehabilitation. The statistical analysis will follow the intention-to-treat principles.

The outcomes of interest are motor function state of the UL, pain intensity, cognitive functions, general physical and emotional status. An integral indicators are the assessment of the patient's quality of life and independence in everyday life activity.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liudmila V Petrova, PhD; Phone Number: +79163940742; Email: ludmila.v.petrova@yandex.ru
• Study Contact Backup: Name: Elena V Kostenko, MD; Phone Number: +79057685856; Email: ekostenko58@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105120
    • Recruiting
    • Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
    • Contact: Elena V Kostenko, MD; Phone Number: +79057685856; Email: ekostenko58@mail.ru
    • Contact: Liudmila V Petrova, PhD; Phone Number: +79166728894; Email: ludmila.v.petrova@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or women aged 18 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
2. Supratentorial IS according to MRI of the brain.
3. The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
4. Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
5. Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
6. Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
7. The patient's ability and willingness to comply with the requirements of this protocol.

Exclusion Criteria:

1. Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
2. Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
3. Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
4. Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
5. Sensory aphasia, gross motor aphasia.
6. Recurrent stroke.
7. Unstable angina and/or heart attack in previous month.
8. Uncontrolled arterial hypertension.
9. Somatic diseases in decompensation stage.
10. Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
11. Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
12. Pregnancy.
13. Lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: digital interactive technology Smart glove "SensoRehab"; 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"; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of correctly performed tasks	percentage of correctly performed tasks while training	Baseline, end of the 2-nd week
change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS	The 6-point Medical Research Council Scale for assessing	Baseline, end of the 2-nd week and 1-month after completing training
changes in spasticity severity	Modified Ashworth Scale: MAS (0 to 4 points)	Baseline, end of the 2-nd week and 1-month after completing training
changes in level of impairment or dependence in daily life	Barthel ADL Index	Baseline, end of the 2-nd week and 1-month after completing training
сhanges in cognitive status	Montreal Cognitive Assessment: МоСА	Baseline, end of the 2-nd week and 1-month after completing training
Presence and severity of depression	The Hospital Anxiety and Depression Scale: HADS. Changes in HADS anxiety and depression scores	Baseline, end of the 2-nd week and 1-month after completing training
Life quality assessment	European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale)	Baseline, end of the 2-nd week and 1-month after completing training

Collaborators and Investigators

• Sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
• Investigators: Principal Investigator: Elena V Kostenko, MD, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: artificial intelligence; ischemic stroke rehabilitation; post-stroke dysfunction of the hand; upper limb medical rehabilitation; digital interactive technology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 9 12112020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No