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NCT Number: NCT05820815

Feasibility and Safety of In-bed Self-exercise 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]

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongno, 03080, South Korea

Location status: Recruiting

Location contact

junghyun kim

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change of The number and percentage of participating sessions

    Time frame: baseline-3weeks

    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.

  2. Change of The number and percentage of completed sessions

    Time frame: baseline-3weeks

    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.

  3. Change of The number and percentage of successful sessions

    Time frame: baseline-3weeks

    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.

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

    Time frame: baseline-3weeks

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

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

    Time frame: baseline-3weeks

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

  6. Change of Rivermead motor assessment

    Time frame: baseline-3weeks-12weeks

    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.

  7. Change of Manual muscle test

    Time frame: baseline-3weeks-12weeks

    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.

  8. Change of Brunnstrom stages of motor recovery

    Time frame: baseline-3weeks-12weeks

    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).

  9. Change of Fugl-Meyer assessment of lower extremity

    Time frame: baseline-3weeks-12weeks

    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.

  10. Change of Berg balance scale

    Time frame: baseline-3weeks-12weeks

    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.

  11. Change of Functional ambulation category

    Time frame: baseline-3weeks-12weeks

    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.

  12. Change of modified Rankin scale

    Time frame: baseline-3weeks-12weeks

    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.

  13. Change of Modified Barthel index

    Time frame: baseline-3weeks-12weeks

    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)

  14. Change of Short-form Health Survery 36 version 2

    Time frame: baseline-3weeks-12weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

JungHyun Kim, prof

CONTACT

[email protected]

01088632341

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Trade, Industry & Energy, Republic of Korea

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2023
Registry last updated
Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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