UMIN-CTR Clinical Trial

Basic information
Public title	Self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Acronym	Self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Scientific Title	Self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Scientific Title:Acronym	Self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Region	Japan

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

Objectives
Narrative objectives1	The purpose of the study is to examine whether self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The total number of steps taken during voluntary training
Key secondary outcomes	1) Total time of voluntary training 2) Time to take a first break during voluntary training 3) Physical activity during voluntary training 4) Apathy scale 5) Depression scale 6) Visual analog scale of motivation

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Self-determined choice of cane for voluntary walking training
Interventions/Control_2	Non-self-determined choice of cane for voluntary walking 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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients who can walk with T shape handle cane in the hospital 2. a Mini Mental Status Examination score of >20 points. No higher brain dysfunction including aphasia 3. patients who agree to participate in this study
Key exclusion criteria	1.patients who have a history of falls in the hospital 2.patients whose voluntary training is limited due to cardiovascular disease or respiratory failure 3. patients who have arthrogryposis, orthopedic disease or pain that prevent them to perform motor tasks used in the study. 4. patients who have psychiatric disease 5. patients who are considered to be inappropriate to participate in the study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Kamiya
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	4338127
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL	053-471-8331
Email	r.kamiya@sis.seirei.or.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Kamiya
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	4338127
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL	053-471-8331
Homepage URL
Email	r.kamiya@sis.seirei.or.jp

Sponsor
Institute	Hamamatsu City Rehabilitation Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Hamamatsu University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu City Rehabilitation Hospital
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel	053-471-8331
Email	r.kamiya@sis.seirei.or.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	浜松市リハビリテーション病院

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 10 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
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	Enrolling by invitation
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 06 Month 29 Day
Anticipated trial start date	2018 Year 07 Month 05 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	2021 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037685