UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028418 |
|---|---|
| Receipt number | R000032485 |
| Scientific Title | Effect of neuromuscular stimulation on muscle volume in acute stroke patients: A randomized trial |
| Date of disclosure of the study information | 2017/07/28 |
| Last modified on | 2022/08/04 06:10:57 |
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Basic information
Public title
Effect of neuromuscular stimulation on muscle volume in acute stroke patients: A randomized trial
Acronym
Effect of neuromuscular stimulation on muscle volume in acute stroke patients: A randomized trial
Scientific Title
Effect of neuromuscular stimulation on muscle volume in acute stroke patients: A randomized trial
Scientific Title:Acronym
Effect of neuromuscular stimulation on muscle volume in acute stroke patients: A randomized trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the preventive effect of skeletal muscle atrophy by neuromuscular electrical stimulation in acute stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of quadriceps muscle thickness measured by ultrasound imaging
Key secondary outcomes
1. Functional ambulation category (FAC)
2. Motricity Index (MI)
3. Trunk control test (TCT)
4. modified Ashworth Scale (MAS)
5. modified Rankin Scale (mRS) at 90 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
NMES is implemented daily (5 days/week) for 30 min on abodominal, thigh and lower leg. The stimulator used was G-TES (Homer Ion, Tokyo, Japan).
Electric stimulation is performed at 20Hz frequency, 250micro sec for pulse width, and 5:2 for on:off cycle.
The intensity levels is set cause visible contractions and be tolerated by the patients.
Interventions/Control_2
Patients in the control group received sham NMES. Sham NMES is implemented daily (5days/week) for 30 min on the same muscle groups with the NMES group. The intensity is set at the minimum value without palpable muscle contractions.
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. first ever unilateral hemispheric stroke
2. hospitalization within 24 hours after onset
3. modified Rankin Scale 0, 1 before stroke
4. NIHSS =>4 at hospitalization
Key exclusion criteria
1. subarachnoid hemorrhage / brain stem or cerebellar stroke
2. Complete recovery within the first 24 hours
3. pacemaker implantation
4. advanced-stage cancer
5. complications of respiratory failure / heart failure
6. technical restrictions regarding NMES implementation
7. inadequate patients judged by physicians or physical therapists
Target sample size
118
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Arakawa |
Organization
Steel Memorial Yawata Hospital
Division name
Center of Stroke and Neurology
Zip code
805-8508
Address
1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL
0936719318
arakawa.sy@ns.yawata-mhp.or.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Yamauchi |
Organization
Steel Memorial Yawata Hospital
Division name
Department of Rehabilitation
Zip code
805-8508
Address
1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL
0936719318
Homepage URL
yamauchi.k@ns.yawata-mhp.or.jp
Sponsor or person
Institute
Steel Memorial Yawata Hospital
Institute
Department
Personal name
Funding Source
Organization
Steel Memorial Yawata 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
ethical review committee of Steel Memorial Yawata Hospital
Address
1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
Tel
093-672-3176
shimono.s@ns.yawata-mhp.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
| 2017 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000032485
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Analysis in progress
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2017 | Year | 07 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032485
