Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: in-bed self-exercises based on EMG-sensor feedback intervention.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Change of Pittsburgh Rehabilitation Participation Scale [Time frame: baseline-3weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
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. PMID 39775073
Identifiers
NCT: NCT05820815 · 0720222116 · 20220150017