UnknownNot Applicable

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

Russia30 participantsStarted 2021-01-11

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, end of the 2-nd week

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

Timeframe: Baseline, 1-month after completing training

Action Research Arm Test (ARAT) Scale dynamic

Timeframe: Baseline, end of the 2-nd week

Action Research Arm Test (ARAT) Scale dynamic

Timeframe: Baseline, 1-month after completing training

Trial details

NCT IDNCT05214521

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-30

Contact for this trial

Liudmila V Petrova, PhD

+79163940742 ludmila.v.petrova@yandex.ru

View on ClinicalTrials.gov More Stroke Rehabilitation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline, end of the 2-nd week

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

Timeframe: Baseline, 1-month after completing training

Action Research Arm Test (ARAT) Scale dynamic

Timeframe: Baseline, end of the 2-nd week

Action Research Arm Test (ARAT) Scale dynamic

Timeframe: Baseline, 1-month after completing training

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria