UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007290 |
|---|---|
| Receipt number | R000008597 |
| Scientific Title | Anti-spastic effects of whole body vibration to the spastic muscles of hemiplegic legs in post-stroke patients |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2012/02/14 16:19:21 |
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Basic information
Public title
Anti-spastic effects of whole body vibration to the spastic muscles of hemiplegic legs in post-stroke patients
Acronym
Anti-spastic effects of whole body vibration
Scientific Title
Anti-spastic effects of whole body vibration to the spastic muscles of hemiplegic legs in post-stroke patients
Scientific Title:Acronym
Anti-spastic effects of whole body vibration
Region
| Japan |
Condition
Condition
Post-stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate whether whole body vibration inhibits spasticity in the hemiplegic legs of post-stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion of trunk, Straight Leg Raising test (SLR), range of motion of ankle, Modified Asworth Scale (MAS), ankle clonus, 10m walk test, questionnare
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
whole body vibration (WBV)
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients were able to walk without assistance using a T-cane or an ankle-foot orthosis. Brunnstrom recovery stage of lower limb >3.
Key exclusion criteria
Patients were excluded from the analysis if they were aged >70 years, or had shown abnormal gait prior to the onset of stroke (such as joint disability or peripheral neuropathy), had a medical condition that limited footbath usage (such as severe cardiopulmonary disease or severe sensory disturbance), had severe aphasia that made it impossible to follow verbal instructions, or had bilateral hemisphere legions or dementia that interfered with the outcome assessments.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagoshima University
Division name
Dept of Rehabilitation
Zip code
Address
TEL
Homepage URL
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 02 | Month | 14 | Day |
Last modified on
| 2012 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008597
