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Effects of In-bed Self-exercises Based on EMG-sensor Feedback on Functional Mobility in Subacute Stroke Patients

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
in-bed self-exercises based on EMG-sensor feedback intervention
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring biofeedback, clinical trial, electromyography, self, stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 19 years and older the onset of the stroke is less than 3months ago Lower extremity weakness due to stroke (MMT =< 4 grade) Modified Rankine Scale 2-5 points Cognitive ability to follow commands Exclusion Criteria: stroke recurrence other neurological abnormalities (e.g. parkinson's disease). severely impaired cognition serious and complex medical conditions(e.g. active cancer) cardiac pacemaker or other implanted electronic system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    in-bed self-exercises based on EMG-sensor feedback intervention

    Conventional rehabilitation

    Arm Description

    Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training. Additional in-bed self-exercises based on EMG-sensor feedback with conventional rehabilitation.

    Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training.

    Outcomes

    Primary Outcome Measures

    Change of Rivermead motor assessment
    The RMA consists of three scales, including gross function, leg and trunk, and arm sections. Each activity must be carried out independently. Allowing his three attempts for each item. The Gross Function section (RMA-gf) consists of 13 items and primarily assesses mobility from sitting to running and gait. The leg and trunk section (RMA-lt) describes individual movements of the trunk (e.g. rolling to the affected side) and leg (e.g. ankle dorsiflexion with the leg extended while lying down). It consists of 10 items to be evaluated. Score '1' if the patient can perform the activity and ' 0' if he cannot. The maximum score equals the number of items. The higher the score, the more normal motor performance is possible. The intra-class correlation coefficients of the Rivermead motor assessment were between 0.88 and 0.95.

    Secondary Outcome Measures

    Change of Manual muscle test
    As a muscle strength measurement test, it is a scale evaluated on a scale of 0-5 according to strength against gravity and resistance. Score '5' if the patient is of Normal strength, ' 0' if he cannot check contraction palpable. In this study, bilateral hip flexion, hip abduction, knee extension, and ankle dorsiflexion muscle strength were measured. MMT had good external and internal efficacy and was not dependent on examiner bias.
    Change of Brunnstrom stages of motor recovery
    The Brunnstrom approach is a classification method that models the motor recovery process after stroke-induced hemiplegia on a six-point ordinal scale. Brunnstrom's stage of recovery covers the progression of complete motor recovery from stage 1 of complete flaccidity and no voluntary movement to stage 6, when spasticity disappears, and near-normal isolated joint activities become possible. The Brunnstrom approach focuses on unique patterns associated with stroke recovery, including motor spasticity development, synergistic patterns, and voluntary movements. Brunnstrom had high inter-rater reliability (0.74 to 0.98).
    Change of Fugl-Meyer assessment of lower extremity
    The FMA-LE investigates hip, knee, and ankle movements, and hierarchical recovery is recorded based on Brunnstrom's stages of recovery, from reflex to synergistic and non-synergistic movements. The FMA-LE motor domain uses a 3-point ordinal scale as follows: 0, unable to perform; 1, partially performance; and 2, complete performance. The possible score ranges from 0 to 34. The intra- and inter-rater reliabilities were excellent in early stroke patients.
    Change of Berg balance scale
    The BBS was developed in 1989 by Katherine Berg in three-step survey of 32 health professionals to objectively measure balance and fall risk in community-dwelling older adults. The BBS examines 14 movements of daily life on a 5-point ordinal scale (range 0-4). A score of 0 indicates the lowest level of functioning and a score of 4 indicates normal performance. The total score range is 0-56. The BBS is widely used to assess stroke patients and its test-retest reliability and internal consistency to be excellent.
    Change of Functional ambulation category
    The 6-point rating scale assesses how much human support is required when walking (with or without a personal assistive device).A score of 0 indicates a non-functional ambulator, and scores of 1-3 indicate dependent ambulators. A score of 1 indicates the need for ontinuous manual contact, a score of 2 indicates intermittent or continuous light touch, and a score of 3 indicates supervision or verbal cueing. Scores of 4-5 are independent ambulators, with a score of 4 indicating independent ambulators on horizontal surfaces only and a score of 5 indicating independent ambulators on any surface, including stairs. There was good interrater reliability among examiners of post-stroke patients.
    Change of modified Rankin scale
    mRS is a widely used tool to measure global disability after stroke. The scale classifies disability from 0 (no symptoms at all) to 5 (severe disability). Scoring is performed by the evaluator based on the subject's functional dependence. The mRS is also found to be a psychometrically accepted measure. Intra-rater reliability was excellent.
    Change of Modified Barthel index
    The MBI measures activities of daily living and includes ten activity domains, including bowel management, urinary management, grooming, toilet use, eating, locomotion, walking, dressing, climbing stairs, and bathing. Each activity is given a score ranging from 0 (unable to perform a task) to a maximum of 5, 10, or 15 (fully independent- the exact score depends on the evaluated activity). A total score is obtained by summing points for each of the items. Total scores may range from 0 to 100, with higher scores indicating greater independence. MBI is widely used to assess stroke patients and has a high intra-class correlation coefficient (ICC=.94)
    Change of Pittsburgh Rehabilitation Participation Scale
    The PRPS is a clinician-assessed instrument designed to assess patient participation in treatment. It is rated on a scale of 1 to 6 to measure the patient's effort and activeness to participate in treatment. Score '6' if the patient participated in all exercises and ' 1' if the patient refused the entire session. The PRPS had high interrater reliability(ICC=.96).
    Change of Short-form Health Survery 36 version 2
    The SF-36v2 is a well-studied, self-reported measure of functional health. Each item includes physical functioning, physical role limitation, pain, general medical health, vitality, social functioning, emotional role limitation, mental health, physical component scale, and mental component scale. Scores from 0 to 100 can be obtained through the SF-36v2 scoring software. Higher scores indicate better health status. There was good internal consistency over 0.7 for all subscales of the questionnaire.

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Seoul National University Hospital
    Collaborators
    Ministry of Trade, Industry & Energy, Republic of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05820815
    Brief Title
    Effects of In-bed Self-exercises Based on EMG-sensor Feedback on Functional Mobility in Subacute Stroke Patients
    Official Title
    Effects of In-bed Self-exercises Based on EMG-sensor Feedback on Functional Mobility in Subacute Stroke Patients: a Prospective, Multicenter, Single-blind, Open-label, Exploratory Pilot Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Ministry of Trade, Industry & Energy, Republic of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this to investigate the effect of in-bed self-exercises based on EMG-sensor feedback on functional mobility in subacute stroke patients. The main question is to fucntional mobility, ADL and balance it aims to answer are: [Rivermead motor assessment] [Manual muscle test] [brunnstrom stages of motor recovery] [Fugl Meyer assessment of lower extremity] [Berg balance scale] [Functional ambulation category] [modified Rankin scale] [modified Barthel index] [Pittsburgh Rehabilitation Participation Scale] [Short-form Health Survery 36 version 2]
    Detailed Description
    The intervention group is provided with graded exercise using the in-bed self-exercises based on EMG-sensor feedback according to muscle strength of the hemiplegic lower extremity and Brunnstrom stages of motor recovery in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    biofeedback, clinical trial, electromyography, self, stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    An outcome assessor will be blinded after assignment to interventions by blocking access to the web randomization table operated on the website.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    in-bed self-exercises based on EMG-sensor feedback intervention
    Arm Type
    Experimental
    Arm Description
    Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training. Additional in-bed self-exercises based on EMG-sensor feedback with conventional rehabilitation.
    Arm Title
    Conventional rehabilitation
    Arm Type
    No Intervention
    Arm Description
    Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training.
    Intervention Type
    Device
    Intervention Name(s)
    in-bed self-exercises based on EMG-sensor feedback intervention
    Intervention Description
    It presents the exercise method and amount of exercise for self-exercise and performs self-exercise while receiving feedback from muscle activity during self-exercise.
    Primary Outcome Measure Information:
    Title
    Change of Rivermead motor assessment
    Description
    The RMA consists of three scales, including gross function, leg and trunk, and arm sections. Each activity must be carried out independently. Allowing his three attempts for each item. The Gross Function section (RMA-gf) consists of 13 items and primarily assesses mobility from sitting to running and gait. The leg and trunk section (RMA-lt) describes individual movements of the trunk (e.g. rolling to the affected side) and leg (e.g. ankle dorsiflexion with the leg extended while lying down). It consists of 10 items to be evaluated. Score '1' if the patient can perform the activity and ' 0' if he cannot. The maximum score equals the number of items. The higher the score, the more normal motor performance is possible. The intra-class correlation coefficients of the Rivermead motor assessment were between 0.88 and 0.95.
    Time Frame
    baseline-3weeks-12weeks
    Secondary Outcome Measure Information:
    Title
    Change of Manual muscle test
    Description
    As a muscle strength measurement test, it is a scale evaluated on a scale of 0-5 according to strength against gravity and resistance. Score '5' if the patient is of Normal strength, ' 0' if he cannot check contraction palpable. In this study, bilateral hip flexion, hip abduction, knee extension, and ankle dorsiflexion muscle strength were measured. MMT had good external and internal efficacy and was not dependent on examiner bias.
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Brunnstrom stages of motor recovery
    Description
    The Brunnstrom approach is a classification method that models the motor recovery process after stroke-induced hemiplegia on a six-point ordinal scale. Brunnstrom's stage of recovery covers the progression of complete motor recovery from stage 1 of complete flaccidity and no voluntary movement to stage 6, when spasticity disappears, and near-normal isolated joint activities become possible. The Brunnstrom approach focuses on unique patterns associated with stroke recovery, including motor spasticity development, synergistic patterns, and voluntary movements. Brunnstrom had high inter-rater reliability (0.74 to 0.98).
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Fugl-Meyer assessment of lower extremity
    Description
    The FMA-LE investigates hip, knee, and ankle movements, and hierarchical recovery is recorded based on Brunnstrom's stages of recovery, from reflex to synergistic and non-synergistic movements. The FMA-LE motor domain uses a 3-point ordinal scale as follows: 0, unable to perform; 1, partially performance; and 2, complete performance. The possible score ranges from 0 to 34. The intra- and inter-rater reliabilities were excellent in early stroke patients.
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Berg balance scale
    Description
    The BBS was developed in 1989 by Katherine Berg in three-step survey of 32 health professionals to objectively measure balance and fall risk in community-dwelling older adults. The BBS examines 14 movements of daily life on a 5-point ordinal scale (range 0-4). A score of 0 indicates the lowest level of functioning and a score of 4 indicates normal performance. The total score range is 0-56. The BBS is widely used to assess stroke patients and its test-retest reliability and internal consistency to be excellent.
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Functional ambulation category
    Description
    The 6-point rating scale assesses how much human support is required when walking (with or without a personal assistive device).A score of 0 indicates a non-functional ambulator, and scores of 1-3 indicate dependent ambulators. A score of 1 indicates the need for ontinuous manual contact, a score of 2 indicates intermittent or continuous light touch, and a score of 3 indicates supervision or verbal cueing. Scores of 4-5 are independent ambulators, with a score of 4 indicating independent ambulators on horizontal surfaces only and a score of 5 indicating independent ambulators on any surface, including stairs. There was good interrater reliability among examiners of post-stroke patients.
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of modified Rankin scale
    Description
    mRS is a widely used tool to measure global disability after stroke. The scale classifies disability from 0 (no symptoms at all) to 5 (severe disability). Scoring is performed by the evaluator based on the subject's functional dependence. The mRS is also found to be a psychometrically accepted measure. Intra-rater reliability was excellent.
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Modified Barthel index
    Description
    The MBI measures activities of daily living and includes ten activity domains, including bowel management, urinary management, grooming, toilet use, eating, locomotion, walking, dressing, climbing stairs, and bathing. Each activity is given a score ranging from 0 (unable to perform a task) to a maximum of 5, 10, or 15 (fully independent- the exact score depends on the evaluated activity). A total score is obtained by summing points for each of the items. Total scores may range from 0 to 100, with higher scores indicating greater independence. MBI is widely used to assess stroke patients and has a high intra-class correlation coefficient (ICC=.94)
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Pittsburgh Rehabilitation Participation Scale
    Description
    The PRPS is a clinician-assessed instrument designed to assess patient participation in treatment. It is rated on a scale of 1 to 6 to measure the patient's effort and activeness to participate in treatment. Score '6' if the patient participated in all exercises and ' 1' if the patient refused the entire session. The PRPS had high interrater reliability(ICC=.96).
    Time Frame
    baseline-3weeks-12weeks
    Title
    Change of Short-form Health Survery 36 version 2
    Description
    The SF-36v2 is a well-studied, self-reported measure of functional health. Each item includes physical functioning, physical role limitation, pain, general medical health, vitality, social functioning, emotional role limitation, mental health, physical component scale, and mental component scale. Scores from 0 to 100 can be obtained through the SF-36v2 scoring software. Higher scores indicate better health status. There was good internal consistency over 0.7 for all subscales of the questionnaire.
    Time Frame
    baseline-3weeks-12weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 19 years and older the onset of the stroke is less than 3months ago Lower extremity weakness due to stroke (MMT =< 4 grade) Modified Rankine Scale 2-5 points Cognitive ability to follow commands Exclusion Criteria: stroke recurrence other neurological abnormalities (e.g. parkinson's disease). severely impaired cognition serious and complex medical conditions(e.g. active cancer) cardiac pacemaker or other implanted electronic system
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    JungHyun Kim, prof
    Phone
    01088632341
    Email
    kiking0@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Woo Hyung Lee, prof
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Byung-Mo Oh, prof
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Han Gil Seo, prof
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sung Eun Hyun, prof
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hye Jung Park, prof
    Organizational Affiliation
    National Traffic Injury Rehabilitation Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Geun Young Kim, B.S.
    Organizational Affiliation
    National Traffic Injury Rehabilitation Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jung Hyun Kim, prof
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of In-bed Self-exercises Based on EMG-sensor Feedback on Functional Mobility in Subacute Stroke Patients

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