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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018667
Receipt No. 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

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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
Email 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
Email pt@nhs.hosp.go.jp

Sponsor
Institute National Hospital Organization East-Saitama National Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021609

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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