UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033289
Receipt number 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 2021/01/05 15:12:59

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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 or person

Institute

Hamamatsu City Rehabilitation Hospital

Institute

Department

Personal name



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

Value
https://center6.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