Stroke RehabilitationNCT05214521
Digital Interactive Technologies in Rehabilitation of Post-sroke Patients With Impaired Fine Function of the Hand
A study testing digital interactive technology Smart glove "SensoRehab" in people with Stroke Rehabilitation, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- digital interactive technology Smart glove "SensoRehab"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jan 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, 105120
Liudmila V Petrova, PhD, +79166728894, ludmila.v.petrova@yandex.ru
Elena V Kostenko, MD, +79057685856, ekostenko58@mail.ru
About this study
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
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.
Read the 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.
- Conditions
- Stroke Rehabilitation
- Being tested
- digital interactive technology Smart glove "SensoRehab"
- Keywords
- post-stroke dysfunction of the hand, upper limb medical rehabilitation, digital interactive technology, artificial intelligence, ischemic stroke rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: digital interactive technology Smart glove "SensoRehab" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1-month after completing training
Secondary outcomes (7)
percentage of correctly performed tasks
percentage of correctly performed tasks while training
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, end of the 2-nd week and 1-month after completing training
сhanges in cognitive status
Montreal Cognitive Assessment: МоСА
Measured: 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
Measured: 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)
Measured: Baseline, end of the 2-nd week and 1-month after completing training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start11 Jan 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- an open-label observational trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena V Kostenko, MD, Principal investigator, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214521
- Sponsor's protocol ID
- 9 12112020
- Status last verified
- May 2022
- First submitted
- 14 Jan 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05214521
- Acronym / sponsor ID
- 9 12112020
- Conditions
- Stroke Rehabilitation
- Keywords
- post-stroke dysfunction of the hand, upper limb medical rehabilitation, digital interactive technology, artificial intelligence, ischemic stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports MedicineUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- an open-label observational trial
| Arm | Type | Receives |
|---|---|---|
| digital interactive technology Smart glove "SensoRehab" | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | digital interactive technology Smart glove "SensoRehab" |
Primary outcome
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
Time frame: Baseline, end of the 2-nd week
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
Time frame: Baseline, 1-month after completing training
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
Time frame: Baseline, end of the 2-nd week
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
Time frame: Baseline, 1-month after completing training
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.
7 secondary outcomes
percentage of correctly performed tasks
Time frame: Baseline, end of the 2-nd week
change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
changes in spasticity severity
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
changes in level of impairment or dependence in daily life
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
сhanges in cognitive status
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
Presence and severity of depression
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
Life quality assessment
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena V Kostenko, MD principal investigator
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital interactive technology Smart glove "SensoRehab" in people with Stroke Rehabilitation, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liudmila V Petrova, PhD (+79163940742, ludmila.v.petrova@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic (time frame: Baseline, end of the 2-nd week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.