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.
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.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno, 03080
junghyun kim
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
The duration and percentage of participating sessions during self-exercise
Participation time and ratio of self-exercise performed by the subject
Measured: baseline-3weeks
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
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
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
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
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
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
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
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
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.
- First posted20 Apr 2023
- Study start25 Oct 2023
- Primary completion25 Mar 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Responsible party
- Sponsor
- Investigators
- Woo Hyung Lee, prof, Principal investigator, Seoul National University HospitalByung-Mo Oh, prof, Study director, Seoul National University HospitalHan Gil Seo, prof, Study director, Seoul National University HospitalSung Eun Hyun, prof, Study director, Seoul National University HospitalHye Jung Park, prof, Study director, National Traffic Injury Rehabilitation HospitalGeun Young Kim, B.S., Study director, National Traffic Injury Rehabilitation HospitalJung Hyun Kim, prof, Study director, Seoul National University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820815
- Acronym / sponsor ID
- 0720222116
- Conditions
- Stroke
- Keywords
- biofeedback, clinical trial, electromyography, self, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-bed self-exercises based on EMG-sensor feedback intervention | Experimental | Device: in-bed self-exercises based on EMG-sensor feedback 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. Additional in-bed self-exercises based on EMG-sensor feedback with conventional rehabilitation. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-bed self-exercises based on EMG-sensor feedback interventionIt presents the exercise method and amount of exercise for self-exercise and performs self-exercise while receiving feedback from muscle activity during self-exercise. | Device | in-bed self-exercises based on EMG-sensor feedback intervention |
Primary outcome
Change of Pittsburgh Rehabilitation Participation Scale
Time frame: baseline-3weeks
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).
14 secondary outcomes
Change of The number and percentage of participating sessions
Time frame: baseline-3weeks
Change of The number and percentage of completed sessions
Time frame: baseline-3weeks
Change of The number and percentage of successful sessions
Time frame: baseline-3weeks
Change of The mean amplitude of muscle contractions in a session
Time frame: baseline-3weeks
The duration and percentage of participating sessions during self-exercise
Time frame: baseline-3weeks
Change of Rivermead motor assessment
Time frame: baseline-3weeks-12weeks
Change of Manual muscle test
Time frame: baseline-3weeks-12weeks
Change of Brunnstrom stages of motor recovery
Time frame: baseline-3weeks-12weeks
Change of Fugl-Meyer assessment of lower extremity
Time frame: baseline-3weeks-12weeks
Change of Berg balance scale
Time frame: baseline-3weeks-12weeks
Change of Functional ambulation category
Time frame: baseline-3weeks-12weeks
Change of modified Rankin scale
Time frame: baseline-3weeks-12weeks
Change of Modified Barthel index
Time frame: baseline-3weeks-12weeks
Change of Short-form Health Survery 36 version 2
Time frame: baseline-3weeks-12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Derived from this study: PubMed 39775073Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Woo Hyung Lee, prof principal investigator
Seoul National University Hospital
Byung-Mo Oh, prof study director
Seoul National University Hospital
Han Gil Seo, prof study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
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.