UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018667 |
|---|---|
| Receipt number | R000021609 |
| Scientific Title | Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2016/11/16 16:12:47 |
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Basic information
Public title
Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial
Acronym
Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial
Scientific Title
Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial
Scientific Title:Acronym
Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial
Region
| Japan |
Condition
Condition
Hospitalized patients with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that utility of core stability training to improvement of trunk performance, balance and mobility for stroke hemiplegia patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Trunk performance (Trunk Impairment Scale) of post-intervention
Key secondary outcomes
1. flexibility of the lower trunk (pelvic tilt range of motion on sagittal plane)
2. balance ability (the Balance Evaluation Systems Test-brief version)
3. performance of gait (the Timed "Up and Go" test)
4. level of dependency during walking (the Functional Ambulation Categories)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
core stabilization training at 20 minutes of within daily training session, 5 times a week, for 4 weeks
Interventions/Control_2
conventional rehabilitation program only
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. a history of first stroke
2. the definite diagnosis of stroke based on computed tomography and/or magnetic resonance imaging scans
3. supratentorial and hemispheric lesion
4. more than 1 month postonset.
Key exclusion criteria
1. age 80 year and older
2. inability to keep the sitting position for 30 seconds
3. communication problems
4. comorbidities affecting motor performance such as orthopedic and neurological disorders that could influence postural control
5. maximum trunk performance score at the start of the study
6.declined to participant.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koshiro Haruyama |
Organization
National Hospital Organization East-Saitama National Hospital
Division name
Department of Rehabilitation Medicine, Physical Therapy
Zip code
Address
4147 Kurohama, Hasuda, Saitama 349-0196, Japan
TEL
048-768-1161
pt@nhs.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koshiro Haruyama |
Organization
National Hospital Organization East-Saitama National Hospital
Division name
Department of Rehabilitation Medicine, Physical Therapy
Zip code
Address
4147 Kurohama, Hasuda, Saitama 349-0196, Japan
TEL
048-768-1161
Homepage URL
pt@nhs.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization East-Saitama National Hospital
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
国立病院機構東埼玉病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2015 | Year | 08 | Month | 13 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021609
