Clinical trial NCT05820815: Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: biofeedback
clinical trial
electromyography
self
stroke
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
First posted: 2023-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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

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.

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

Primary outcomes:
measure: Change of Pittsburgh Rehabilitation Participation Scale
timeFrame: baseline-3weeks
Secondary outcomes:
measure: Change of The number and percentage of participating sessions
timeFrame: baseline-3weeks
measure: Change of The number and percentage of completed sessions
timeFrame: baseline-3weeks
measure: Change of The number and percentage of successful sessions
timeFrame: baseline-3weeks
measure: Change of The mean amplitude of muscle contractions in a session
timeFrame: baseline-3weeks
measure: The duration and percentage of participating sessions during self-exercise
timeFrame: baseline-3weeks
measure: Change of Rivermead motor assessment
timeFrame: baseline-3weeks-12weeks
measure: Change of Manual muscle test
timeFrame: baseline-3weeks-12weeks
measure: Change of Brunnstrom stages of motor recovery
timeFrame: baseline-3weeks-12weeks
measure: Change of Fugl-Meyer assessment of lower extremity
timeFrame: baseline-3weeks-12weeks
measure: Change of Berg balance scale
timeFrame: baseline-3weeks-12weeks
measure: Change of Functional ambulation category
timeFrame: baseline-3weeks-12weeks
measure: Change of modified Rankin scale
timeFrame: baseline-3weeks-12weeks
measure: Change of Modified Barthel index
timeFrame: baseline-3weeks-12weeks
measure: Change of Short-form Health Survery 36 version 2
timeFrame: baseline-3weeks-12weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno
Study officials:
affiliation: Seoul National University Hospital
name: Woo Hyung Lee, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Byung-Mo Oh, prof
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Han Gil Seo, prof
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Sung Eun Hyun, prof
role: STUDY_DIRECTOR
affiliation: National Traffic Injury Rehabilitation Hospital
name: Hye Jung Park, prof
role: STUDY_DIRECTOR
affiliation: National Traffic Injury Rehabilitation Hospital
name: Geun Young Kim, B.S.
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Jung Hyun Kim, prof
role: STUDY_DIRECTOR
References: