UMIN-CTR Clinical Trial

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
Email	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
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	ethical review committee of Steel Memorial Yawata Hospital
Address	1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
Tel	093-672-3176
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032485