UMIN-CTR Clinical Trial

Basic information
Public title	Influence of walking training using a Body Weight Support walker on walking speed of hemiplegic stroke patients
Acronym	Influence of walking training using a Body Weight Support walker on walking speed of hemiplegic stroke patients
Scientific Title	Influence of overground walking training using a Body Weight Support walker on the walking speed of hemiplegic stroke patients
Scientific Title:Acronym	Influence of overground walking training using a Body Weight Support walker on the walking speed of stroke patients
Region	Japan

Condition
Condition	Hemiplegic patients after stroke
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the Influence of walking training using a Body Weight Support (BWS) walker on walking speed in hemiplegic patients after stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Walking Speed(Comfortable Walking Speed, Maximum Walking Speed) Measurements are taken before and after each of normal walking training, 0% BWS walking training using a BWS walker, and 20% BWS walking training using a BWS walker.
Key secondary outcomes	Gait Symmetry (Symmetry ratio), Gait Variability(Coefficient of Variation:CV), Step Length, Stride Length, Cadence, Stance Time, Swing Time, Double Support Time

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Perform normal walking training for 10 minutes a day.
Interventions/Control_2	Perform walking training with 0% BWS using a BWS walker for 10 minutes a day.
Interventions/Control_3	Perform walking training with 20% BWS using a BWS walker for 10 minutes a day.
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.Subjects with developed hemiplegia after the first stroke. 2.Subjects with can walk without assistance.(Functional Ambulation Category of 3 points or more)
Key exclusion criteria	1.Subjects with impaired consciousness. (Japan Coma Scale of 3 or more) 2.Subjects with cognitive decline(Mini Mental State Examination 20 points or less), severe aphasic symptoms, higher brain dysfunction that are difficult to understand in this study. 3. Subjects who are unable to walk before the onset of stroke. 4.Subjects with cardiovascular or respiratory disease that limit training. 5.Subjects with lower limb osteoarthritis that limit training. 6.Subjects with pain in harness or suspension. 7.Subjects with body weighing more than 100 kg.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Taishi Middle name Last name Kikkawa
Organization	Ushioda General Hospital
Division name	Department of Rehabilitation
Zip code	230-0001
Address	1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL	045-574-1011
Email	mrcl.kikkawa@gmail.com

Public contact
Name of contact person	1st name Taishi Middle name Last name Kikkawa
Organization	Ushioda General Hospital
Division name	Department of Rehabilitation
Zip code	230-0001
Address	1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL	045-574-1011
Homepage URL
Email	mrcl.kikkawa@gmail.com

Sponsor
Institute	Ushioda General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	KANAGAWA UNIVERSITY of HUMAN SERVICES
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KANAGAWA UNIVERSITY of HUMAN SERVICES
Address	1-10-1 Heisei,Yokosuka,Kanagawa,Japan
Tel	046-828-2530
Email	kenkyuurinri@kuhs.ac.jp

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	2020 Year 03 Month 02 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	23
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	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 03 Month 12 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 28 Day
Last modified on	2021 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045210