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

NCT05820815 | Recruiting DMC

• 2 other identifiers: 072022211620220150017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

biofeedback; clinical trial; electromyography; self; stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline-3weeks

Secondary Outcomes (14)

• Change of The number and percentage of participating sessions

  baseline-3weeks

• Change of The number and percentage of completed sessions

  baseline-3weeks

• Change of The number and percentage of successful sessions

  baseline-3weeks

• Change of The mean amplitude of muscle contractions in a session

  baseline-3weeks

• The duration and percentage of participating sessions during self-exercise

  baseline-3weeks

Study Arms (2)

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

EXPERIMENTAL

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.

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

Conventional rehabilitation

NO 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.

Interventions

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

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno, 03080, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39775073 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Woo Hyung Lee, prof

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Byung-Mo Oh, prof

  Seoul National University Hospital

  STUDY DIRECTOR

• Han Gil Seo, prof

  Seoul National University Hospital

  STUDY DIRECTOR

• Sung Eun Hyun, prof

  Seoul National University Hospital

  STUDY DIRECTOR

• Hye Jung Park, prof

  National Traffic Injury Rehabilitation Hospital

  STUDY DIRECTOR

• Geun Young Kim, B.S.

  National Traffic Injury Rehabilitation Hospital

  STUDY DIRECTOR

• Jung Hyun Kim, prof

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

JungHyun Kim, prof

CONTACT

01088632341; kiking0@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An outcome assessor will be blinded after assignment to interventions by blocking access to the web randomization table operated on the website.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 20, 2023
• Study Start: October 25, 2023
• Primary Completion: March 25, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)