UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060710 |
|---|---|
| Receipt number | R000069456 |
| Scientific Title | Effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation on bilateral quadriceps in hemiplegic patients in a convalescent rehabilitation ward: A randomized crossover study |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2026/02/20 10:29:48 |
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Basic information
Public title
Effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation on bilateral quadriceps in hemiplegic patients in a convalescent rehabilitation ward: A randomized crossover study
Acronym
stroke
sit-to-stand self-exercise combined with neuromuscular electrical stimulation
Scientific Title
Effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation on bilateral quadriceps in hemiplegic patients in a convalescent rehabilitation ward: A randomized crossover study
Scientific Title:Acronym
stroke
sit-to-stand self-exercise combined with neuromuscular electrical stimulation
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation (NMES) on the bilateral quadriceps, in addition to conventional rehabilitation, on lower limb motor function, standing balance, and walking ability in hemiplegic patients admitted to a convalescent rehabilitation ward, using a randomized crossover design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Manual muscle strength testing using a handheld dynamometer
Key secondary outcomes
Motricity Index
Fugl-Meyer Assessment-Lower Extremity
Hand grip
Calf circumference
Five-Times Sit-to-Stand Test
Berg Balance Scale
Functional Ambulation Categories
10m walking test
6-minute walk test
Functional Independence Measure
Physical activity level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional rehabilitation
Period A: Conventional rehabilitation only (60 min/day).
Duration: 2 weeks for each phase, with a 1-week washout period (5 weeks in total).
Interventions/Control_2
Repetitive sit-to-stand self-exercise combined with NMES, in addition to conventional rehabilitation
Period B: Repetitive sit-to-stand exercise with NMES (1 set/day, 3 days/week) plus conventional rehabilitation (60 min/day).
Duration: 2 weeks for each phase, with a 1-week washout period (5 weeks in total).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 to 85 years.
2. Patients admitted to the convalescent rehabilitation ward of our hospital (within 180 days after stroke onset).
3. Patients with their first-ever stroke, classified as either cerebral infarction or intracerebral hemorrhage.
4. Patients presenting with mild to moderate lower limb motor paralysis.
5. Patients with a Functional Ambulation Categories (FAC) score of 1 or higher.
6. Patients with stable systemic conditions, including blood pressure, pulse rate, and blood glucose levels.
7. Patients capable of providing written informed consent personally.
Key exclusion criteria
1. Patients with significant cognitive impairment that interferes with the execution of repetitive sit-to-stand exercise with NMES (Mini-Mental State Examination [MMSE] score of 23 points or less).
2. Patients with contraindications to electrical stimulation therapy, including cardiac pacemakers, pregnancy, malignant tumors, active bleeding sites, infections, or areas of inflammation.
3. Patients deemed unable to perform self-exercises due to exertional dyspnea, heart failure, arrhythmia, myocardial infarction, or other cardiovascular conditions.
4. Patients with a history of neurological or orthopedic diseases affecting trunk or lower limb function, or those with comorbidities (e.g., degenerative diseases, scoliosis) whose symptoms might be exacerbated by functional training.
5. Patients with severe hepatic impairment, renal impairment, or cardiovascular disease.
6. Patients with severe sensory impairment, ataxia, or higher brain dysfunction such as aphasia, which makes the execution of repetitive sit-to-stand exercise with NMES difficult.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kodai |
| Middle name | |
| Last name | Miyara |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomino, Tamana, Kumamoto
TEL
0968-75-1800
k-miyara@kyushu-ns.ac.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Miyara |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomino, Tamana, Kumamoto
TEL
0968-75-1800
Homepage URL
k-miyara@kyushu-ns.ac.jp
Sponsor or person
Institute
Kyushu University of Nursing and Social Welfare
Institute
Department
Personal name
Funding Source
Organization
Kyushu University of Nursing and Social Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hakujyuji Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakujyuji Hospital
Address
4-3-1 Ishimaru, Nishi-ku, Fukuoka-shi, Fukuoka
Tel
0968-75-1800
k-miyara@kyushu-ns.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
白十字リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069456
