UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006426 |
|---|---|
| Receipt number | R000007628 |
| Scientific Title | Effects of peripheral sensory nerve stimulation combined with task-oriented training on arm function in subacute stroke patients |
| Date of disclosure of the study information | 2011/09/28 |
| Last modified on | 2012/04/28 09:44:15 |
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Basic information
Public title
Effects of peripheral sensory nerve stimulation combined with task-oriented training on arm function in subacute stroke patients
Acronym
Effects of peripheral sensory nerve stimulation and task-oriented training in stroke patients
Scientific Title
Effects of peripheral sensory nerve stimulation combined with task-oriented training on arm function in subacute stroke patients
Scientific Title:Acronym
Effects of peripheral sensory nerve stimulation and task-oriented training 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 feasibility of undertaking a randomized crossover trial of peripheral sensory nerve stimulation combined with task-oriented training in stroke patients during inpatient rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Wolf Motor Function Test, Box and Block Test
Key secondary outcomes
Pinch strength, grip strength, fatigue levels
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Peripheral sensory nerve stimulation combined with task-oriented training (1 hour/session, 6 days a week)
Interventions/Control_2
Task-oriented training alone(1 hour/session, 6 days a week)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemiparesis caused by single stroke (onset <6 months), normal consciousness with stable medical and neurological status, mini-mental state examination score of >23, and ability to perform lateral, pulp pinch, and shoulder flexion with the paretic arm (Fugl-Meyer Assessment of upper extremity of >60%, and Brunnstrom recovery stage of upper limb and hand of ≥4).
Key exclusion criteria
Contraindications for electrical stimulation (e.g., a pacemaker), severe sensory deficits, other neurological disorders, severe heart or lung disease, severe aphasia, apraxia, or visuospatial disorders, and inability to give informed consent form.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koki Ikuno |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Ikuno |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
k.ikuno@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitaiton Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Terashita Hospital
Name of secondary funder(s)
Kio University
IRB Contact (For public release)
Organization
Address
Tel
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
西大和リハビリテーション病院（奈良県），寺下病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
http://cre.sagepub.com/content/early/2012/04/12/0269215512441476.abstract
Publication of results
Published
Result
URL related to results and publications
http://cre.sagepub.com/content/early/2012/04/12/0269215512441476.abstract
Number of participants that the trial has enrolled
Results
Within-group comparison showed significant improvements in the Wolf Motor Function
Test mean time after the peripheral sensory nerve
stimulation combined with task-oriented training periods in the immediate group. In between group comparison, the immediate group showed larger improvements than the delayed groups in the Wolf Motor Function Test(P<.05).
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2012 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007628
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
