Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke

NCT ID: NCT05820815

Last Updated: 2025-06-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2026-12-01

Brief Summary

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The goal of this to investigate the feasibility and safety of in-bed self-exercises based on EMG-sensor feedback in subacute stroke patients. The main question is feasibility and safety. It aims to answer are:

\[Pittsburgh Rehabilitation Participation Scale\] \[The number and percentage of participating sessions\] \[The number and percentage of completed sessions\] \[The number and percentage of successful sessions\] \[The mean amplitude of muscle contractions in a session\] \[The duration and percentage of participating sessions during self-exercise\] \[Rivermead motor assessment\] \[Manual muscle test\] \[brunnstrom stages of motor recovery\] \[Fugl Meyer assessment of lower extremity\] \[Berg balance scale\] \[Functional ambulation category\] \[modified Rankin scale\] \[modified Barthel index\] \[Short-form Health Survery 36 version 2\]

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
An outcome assessor will be blinded after assignment to interventions by blocking access to the web randomization table operated on the website.

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JungHyun Kim, prof

Role: CONTACT

01088632341

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.

Reference Type DERIVED
PMID: 39775073 (View on PubMed)

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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