UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of curved gait training in patients with stroke
Title of the study (Brief title)	Effect of curved gait training
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To quantify the effect of curved gait training in subjects with stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Step length after 8 weeks training
Key secondary outcomes	Gait symmetry, step time, and gait speed before and after 8 weeks training

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Curved gait training, Rest period: 8 weeks, and Gait training in straight line Curved gait training: three times a week for 8 weeks (1) 20 minutes of curved gait training (2) stretching (3) muscle strength training (4) balance training Gait training in straight line: three times a week for 8 weeks (1) 20 minutes of gait training in straight line (2) stretching (3) muscle strength training (4) balance training
Interventions/Control_2	Gait training in straight line, Rest period: 8 weeks, and Curved gait training Gait training in straight line: three times a week for 8 weeks (1) 20 minutes of gait training in straight line (2) stretching (3) muscle strength training (4) balance training Curved gait training: three times a week for 8 weeks (1) 20 minutes of curved gait training (2) stretching (3) muscle strength training (4) balance training
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) hemiparesis resulting from a unilateral cortical or sub-cortical brain lesion (2) >6 months since onset (3) able to walk more than 10 m
Key exclusion criteria	(1) inability to provide informed consent (2) a history of other neurologic, respiratory, cardiovascular, or orthopedic problems that would influence their participation in this study
Target sample size	17

Research contact person
Name of lead principal investigator	Kaoru Sakuma
Organization	Kansai University of Welfare Sciences
Division name	Department of Rehabilitation Sciences
Address	3-11-1, asahigaoka, kashiwara, Osaka 582-0026 Japan
TEL	072-947-5686
Email	ksakuma@tamateyama.ac.jp

Public contact
Name of contact person	Kaoru Sakuma
Organization	Kansai University of Welfare Sciences
Division name	Department of Rehabilitation Sciences
Address	3-11-1, asahigaoka, kashiwara, Osaka 582-0026 Japan
TEL	072-947-5686
Homepage URL
Email	ksakuma@tamateyama.ac.jp

Sponsor
Institute	Kansai University of Welfare Sciences
Institute
Department

Funding Source
Organization	Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 16 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2016 Year 05 Month 08 Day
Anticipated trial start date	2016 Year 06 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 15 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025618