UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of core stability training on the trunk function and balance performance in stroke patients: a randomized controlled trial
Title of the study (Brief title)	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	Koshiro Haruyama
Organization	National Hospital Organization East-Saitama National Hospital
Division name	Department of Rehabilitation Medicine, Physical Therapy
Address	4147 Kurohama, Hasuda, Saitama 349-0196, Japan
TEL	048-768-1161
Email	pt@nhs.hosp.go.jp

Public contact
Name of contact person	Koshiro Haruyama
Organization	National Hospital Organization East-Saitama National Hospital
Division name	Department of Rehabilitation Medicine, Physical Therapy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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