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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033289
Receipt No. R000037685
Scientific Title Self-determined choice of cane facilitates voluntary training for walking in rehabilitation
Date of disclosure of the study information 2018/07/10
Last modified on 2019/07/30

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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
2020 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
2018 Year 07 Month 05 Day
Last modified on
2019 Year 07 Month 30 Day


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

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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