UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056658 |
|---|---|
| Receipt number | R000064758 |
| Scientific Title | Short- and long-term impact of neuromuscular electrical stimulation on skeletal muscle quantity and quality decline in acute stroke patients: a randomized controlled trial. |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2025/01/08 05:37:21 |
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Basic information
Public title
The impact of electrical stimulation therapy on skeletal muscle quantity and quality decline in acute stroke patients.
Acronym
The impact of electrical stimulation therapy on skeletal muscle quantity and quality decline in acute stroke patients.
Scientific Title
Short- and long-term impact of neuromuscular electrical stimulation on skeletal muscle quantity and quality decline in acute stroke patients: a randomized controlled trial.
Scientific Title:Acronym
Short- and long-term impact of neuromuscular electrical stimulation on skeletal muscle quantity and quality decline in acute stroke patients
Region
| Japan |
Condition
Condition
Hospitalized patients immediately after stroke onset.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether early electrical stimulation therapy can prevent the short-term decline in skeletal muscle quantity and quality in stroke patients, and to examine its impact on long-term daily activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle cross-sectional area and intramuscular adipose tissue assessed by computed tomography.
Key secondary outcomes
Muscle thickness and muscle echo intensity by ultrasound device.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the electrical stimulation group, electrical stimulation therapy (at a level where muscle contractions are visibly noticeable) will be administered once daily for at least 5 days, in addition to standard rehabilitation.
Interventions/Control_2
In the sham stimulation group, sensory-level electrical stimulation will be administered as sham therapy in addition to standard rehabilitation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients hospitalized within 48 hours after stroke onset.
2.Patients who were capable of independent living prior to hospitalization.
3.Patients with motor paralysis in one upper limb and one lower limb, who were able to walk independently at the time of admission.
4.Patients without severe cardiovascular or respiratory diseases.
Only those who meet all four of the above criteria will be included.
Key exclusion criteria
1.Patients under 18 years of age.
2.Patients for whom measurements are difficult to perform.
3.Patients diagnosed with brainstem or cerebellar infarction or hemorrhage without unilateral motor paralysis.
4.Patients with motor paralysis in all four limbs.
5.Patients who were unable to get out of bed within the first week of hospitalization.
Those who meet any of the above five criteria will be excluded from the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Yamauchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
Department of Rehabilitation
Zip code
507-8522
Address
5-161, Maehata-cho, Tajimi-shi, Gifu, Japan
TEL
0572-22-5311
yamauchi-wataru@tajimi-hospital.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Yamauchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
Department of Rehabilitation
Zip code
507-8522
Address
5-161, Maehata-cho, Tajimi-shi, Gifu, Japan
TEL
0572-22-5311
Homepage URL
yamauchi-wataru@tajimi-hospital.jp
Sponsor or person
Institute
Gifu Prefectural Tajimi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Prefectural Tajimi Hospital Ethics Committee
Address
5-161, Maehata-cho, Tajimi-shi, Gifu, Japan
Tel
0572-22-5311
yamauchi-wataru@tajimi-hospital.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 | 01 | Month | 13 | 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
| 2024 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064758
