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StrokeNCT05820815

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

A study testing in-bed self-exercises based on EMG-sensor feedback intervention in people with Stroke, run by Seoul National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke
What is being tested?
in-bed self-exercises based on EMG-sensor feedback intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
25 Oct 2023to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JungHyun Kim, prof contact

01088632341

kiking0@naver.com

South Korea1 site, 1 recruiting
  • Seoul National University Hospital

    Seoul, Jongno, 03080

    junghyun kim

    Recruiting

Other trials in South Korea

About this study

Official title: Protocol for a Single-blind Randomized Controlled Clinical Trial to Investigate the Feasibility and Safety of In-bed Self-exercise Based on Electromyography Sensor Feedback in Patients With Subacute Stroke

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]

Read the 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.

Conditions
Stroke
Being tested
in-bed self-exercises based on EMG-sensor feedback intervention
Keywords
biofeedback, clinical trial, electromyography, self, stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • in-bed self-exercises based on EMG-sensor feedback interventionDevice

    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.

Study groups in NCT05820815
Study groupRoleWhat they receive
in-bed self-exercises based on EMG-sensor feedback interventionExperimentalConventional 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.
Receives: Device: in-bed self-exercises based on EMG-sensor feedback intervention
Conventional rehabilitationNo interventionConventional 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline-3weeks

Secondary outcomes (14)
  1. Change of The number and percentage of participating sessions

    A participating sessions is defined as a session in which the number of muscle contraction is more than one and the amplitude of the one or more targeted muscles is more than 20% of MVIC in each muscle contraction.

    Measured: baseline-3weeks

  2. Change of The number and percentage of completed sessions

    A completed session is defined as a session in which the percentage of targeted muscle contractions is more than 90% of total muscle contractions and the amplitude of the one or more targeted muscle is more than 10% of MVIC in each muscle contraction.

    Measured: baseline-3weeks

  3. Change of The number and percentage of successful sessions

    A successful session is defined as a session in which the percentage of targeted muscle contractions is more than 90% of total muscle contractions and the amplitude of the one or more targeted muscle is more than 50% of MVIC in each muscle contraction.

    Measured: baseline-3weeks

  4. Change of The mean amplitude of muscle contractions in a session

    Average change in peak amplitude of muscle contractions in self-exercise performed by the subject

    Measured: baseline-3weeks

  5. The duration and percentage of participating sessions during self-exercise

    Participation time and ratio of self-exercise performed by the subject

    Measured: baseline-3weeks

  6. 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.

    Measured: baseline-3weeks-12weeks

  7. 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.

    Measured: baseline-3weeks-12weeks

  8. 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).

    Measured: baseline-3weeks-12weeks

  9. 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.

    Measured: baseline-3weeks-12weeks

  10. 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.

    Measured: baseline-3weeks-12weeks

  11. 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.

    Measured: baseline-3weeks-12weeks

  12. 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.

    Measured: baseline-3weeks-12weeks

  13. 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)

    Measured: baseline-3weeks-12weeks

  14. 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.

    Measured: baseline-3weeks-12weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start25 Oct 2023
  3. Primary completion25 Mar 2025
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820815
Sponsor's protocol ID
0720222116
Other IDs
20220150017
Status last verified
May 2025
First submitted
23 Mar 2023
Last updated
2 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39775073

Questions about this trial

What is this clinical trial studying?

A study testing in-bed self-exercises based on EMG-sensor feedback intervention in people with Stroke, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JungHyun Kim, prof (01088632341, kiking0@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pittsburgh Rehabilitation Participation Scale (time frame: baseline-3weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820815, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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