UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060125 |
|---|---|
| Receipt number | R000068765 |
| Scientific Title | The Effect of Transcutaneous Electrical Nerve Stimulation of the Gluteus Medius combined with Gait Training in Subacute Stroke Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/18 20:44:54 |
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Basic information
Public title
The Effect of Transcutaneous Electrical Nerve Stimulation of the Gluteus Medius combined with Gait Training in Subacute Stroke Patients: A Randomized Controlled Trial
Acronym
The Effect of Transcutaneous Electrical Nerve Stimulation of the Gluteus Medius in Stroke Patient
Scientific Title
The Effect of Transcutaneous Electrical Nerve Stimulation of the Gluteus Medius combined with Gait Training in Subacute Stroke Patients: A Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Transcutaneous Electrical Nerve Stimulation of the Gluteus Medius in Stroke Patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of combining transcutaneous electrical nerve stimulation (TENS) of the gluteus medius with gait training on gait performance in subacute stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10-meter walking test
Acceleration data
(baseline / after 2 weeks of intervention / after 4 weeks of intervention)
Key secondary outcomes
Time Up & Go Test
Berg Balance Scale
Modified Ashworth Scale
Fugl-Meyer Assessment (Lower extremity motor and sensory subscales)
(baseline / after 2 weeks of intervention / after 4 weeks of intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait training combined with transcutaneous electrical nerve stimulation of the gluteus medius (20 min/day, 5 days/week, for 4 weeks)
Interventions/Control_2
Gait training (4 weeks)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with first-ever supratentorial stroke
2) Able to walk >=16 m without a walking aid or assistance
3) Within 90 days after stroke onset
Key exclusion criteria
1) Contraindications to electrical stimulation therapy
2) Bilateral hemispheric lesions
3) Difficulty understanding instructions due to severe higher brain dysfunction or cognitive impairment
4) History of neurological disease
5) History of orthopedic disease
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Kidera |
Organization
Yohkoh rehabilitation hospital
Division name
Department of rehabilitation
Zip code
857-0022
Address
855-1 Yamate-cho, Sasebo City, Nagasaki
TEL
0956-25-3210
tkfmkdr829@gmail.com
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Kidera |
Organization
Yohkoh rehabilitation hospital
Division name
Department of rehabilitation
Zip code
857-0022
Address
855-1 Yamate-cho, Sasebo City, Nagasaki
TEL
0956-25-3210
Homepage URL
tkfmkdr829@gmail.com
Sponsor or person
Institute
Yohkoh rehabilitation hospital
Institute
Department
Personal name
Funding Source
Organization
Yohkoh rehabilitation hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yohkoh rehabilitation hospital clinical research ethics review committee
Address
855-1 Yamate-cho, Sasebo City, Nagasaki
Tel
0956-25-3210
yohkoh@hakujyujikai.or.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 23 | 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 | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068765
