Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke
NCT ID: NCT05820815
Last Updated: 2025-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-10-25
2026-12-01
Brief Summary
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\[Pittsburgh Rehabilitation Participation Scale\] \[The number and percentage of participating sessions\] \[The number and percentage of completed sessions\] \[The number and percentage of successful sessions\] \[The mean amplitude of muscle contractions in a session\] \[The duration and percentage of participating sessions during self-exercise\] \[Rivermead motor assessment\] \[Manual muscle test\] \[brunnstrom stages of motor recovery\] \[Fugl Meyer assessment of lower extremity\] \[Berg balance scale\] \[Functional ambulation category\] \[modified Rankin scale\] \[modified Barthel index\] \[Short-form Health Survery 36 version 2\]
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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in-bed self-exercises based on EMG-sensor feedback intervention
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.
in-bed self-exercises based on EMG-sensor feedback intervention
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.
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.
No interventions assigned to this group
Interventions
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in-bed self-exercises based on EMG-sensor feedback intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Ministry of Trade, Industry & Energy, Republic of Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Woo Hyung Lee, prof
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Byung-Mo Oh, prof
Role: STUDY_DIRECTOR
Seoul National University Hospital
Han Gil Seo, prof
Role: STUDY_DIRECTOR
Seoul National University Hospital
Sung Eun Hyun, prof
Role: STUDY_DIRECTOR
Seoul National University Hospital
Hye Jung Park, prof
Role: STUDY_DIRECTOR
National Traffic Injury Rehabilitation Hospital
Geun Young Kim, B.S.
Role: STUDY_DIRECTOR
National Traffic Injury Rehabilitation Hospital
Jung Hyun Kim, prof
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Jongno, South Korea
Countries
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Central Contacts
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Facility Contacts
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junghyun kim
Role: primary
References
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Kim JH, Oh BM, Seo HG, Hyun SE, Han JT, Kang DH, Lee WH. Protocol for a single-blind randomized controlled clinical trial to investigate the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke. PLoS One. 2024 Dec 30;19(12):e0310178. doi: 10.1371/journal.pone.0310178. eCollection 2024.
Other Identifiers
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20220150017
Identifier Type: OTHER
Identifier Source: secondary_id
0720222116
Identifier Type: -
Identifier Source: org_study_id
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