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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214521
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

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.

Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Device: digital interactive technology Smart glove "SensoRehab" Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: an open-label observational trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. percentage of correctly performed tasks [ Time Frame: Baseline, end of the 2-nd week ]
    percentage of correctly performed tasks while training

  2. 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 ]
    The 6-point Medical Research Council Scale for assessing

  3. changes in spasticity severity [ Time Frame: Baseline, end of the 2-nd week and 1-month after completing training ]
    Modified Ashworth Scale: MAS (0 to 4 points)

  4. 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 ]
    Barthel ADL Index

  5. сhanges in cognitive status [ Time Frame: Baseline, end of the 2-nd week and 1-month after completing training ]
    Montreal Cognitive Assessment: МоСА

  6. Presence and severity of depression [ Time Frame: Baseline, end of the 2-nd week and 1-month after completing training ]
    The Hospital Anxiety and Depression Scale: HADS. Changes in HADS anxiety and depression scores

  7. Life quality assessment [ Time Frame: Baseline, end of the 2-nd week and 1-month after completing training ]
    European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214521


Contacts
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Contact: Liudmila V Petrova, PhD +79163940742 ludmila.v.petrova@yandex.ru
Contact: Elena V Kostenko, MD +79057685856 ekostenko58@mail.ru

Locations
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Russian Federation
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7 Recruiting
Moscow, Russian Federation, 105120
Contact: Liudmila V Petrova, PhD    +79166728894    ludmila.v.petrova@yandex.ru   
Contact: Elena V Kostenko, MD    +79057685856    ekostenko58@mail.ru   
Sponsors and Collaborators
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Investigators
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Principal Investigator: Elena V Kostenko, MD Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
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Responsible Party: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
ClinicalTrials.gov Identifier: NCT05214521    
Other Study ID Numbers: 9 12112020
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine:
post-stroke dysfunction of the hand
upper limb medical rehabilitation
digital interactive technology
artificial intelligence
ischemic stroke rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases