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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028418
Receipt No. 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 2017/07/28

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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
Middle name
Last name Shuji Arakawa
Organization Steel Memorial Yawata Hospital
Division name Center of Stroke and Neurology
Zip code
Address 1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL 093-672-3176
Email arakawa.sy@ns.yawata-mhp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Yamauchi
Organization Steel Memorial Yawata Hospital
Division name Department of Rehabilitation
Zip code
Address 1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL 093-671-9318
Homepage URL
Email yamauchi.k@ns.yawata-mhp.or.jp

Sponsor
Institute Steel Memorial Yawata Hospital
Institute
Department

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
Address
Tel
Email

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
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
2017 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
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
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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