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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

digital interactive technology Smart glove "SensoRehab"

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring post-stroke dysfunction of the hand, upper limb medical rehabilitation, digital interactive technology, artificial intelligence, ischemic stroke rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

digital interactive technology Smart glove "SensoRehab"

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

percentage of correctly performed tasks

percentage of correctly performed tasks while training

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

changes in spasticity severity

Modified Ashworth Scale: MAS (0 to 4 points)

changes in level of impairment or dependence in daily life

Barthel ADL Index

сhanges in cognitive status

Montreal Cognitive Assessment: МоСА

Presence and severity of depression

The Hospital Anxiety and Depression Scale: HADS. Changes in HADS anxiety and depression scores

Life quality assessment

European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale)

Full Information

NCT ID

NCT05214521

First Posted

January 14, 2022

Last Updated

May 15, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05214521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2021 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke Rehabilitation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

an open-label observational trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

digital interactive technology Smart glove "SensoRehab"

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

digital interactive technology Smart glove "SensoRehab"

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, end of the 2-nd week

Title

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

Description

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.

Time Frame

Baseline, 1-month after completing training

Title

Action Research Arm Test (ARAT) Scale dynamic

Description

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.

Time Frame

Baseline, end of the 2-nd week

Title

Action Research Arm Test (ARAT) Scale dynamic

Description

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.

Time Frame

Baseline, 1-month after completing training

Secondary Outcome Measure Information:

Title

percentage of correctly performed tasks

Description

percentage of correctly performed tasks while training

Time Frame

Baseline, end of the 2-nd week

Title

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

Description

The 6-point Medical Research Council Scale for assessing

Time Frame