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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032265
Receipt No. R000036635
Scientific Title Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study
Date of disclosure of the study information 2018/05/07
Last modified on 2020/04/27

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Basic information
Public title Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study
Acronym Efficacy of pedometer monitoring in rehabilitation
Scientific Title Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study
Scientific Title:Acronym Efficacy of pedometer monitoring in rehabilitation
Region
Japan

Condition
Condition Patients admitted to a convalescent rehabilitation ward
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and feasibility of step counts monitoring and feedback for improving gait ability
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change rate of 6 minutes walking distance during intervention period
Key secondary outcomes steps per day, 10 meter walking test,, chair stand test, Berg Balance Scale, Timed Up&Go Test, Falls Efficacy Scale-International

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
Participants wear a pedometer all day except bath time during study period. The participants are instructed to record steps per day by themselves in a diary, and are given feedbacks about step counts and goal settings weekly. They are encouraged to increase steps per day by 10% compared with the average step counts in the previous week.
All the participants undergo physical therapy and occupational therapy, 60 minutes per day each, 6 days a week throughout the study period.
Interventions/Control_2 Control group
Participants wear a pedometer all day except bath time during study period. For the control group, not the participants themselves but examiners record steps per day; and feedbacks about step counts are not given.
All the participants undergo physical therapy and occupational therapy, 60 minutes per day each, 6 days a week throughout the study period.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Consent to participate in the study
2. Functional Ambulation Category 3 (Dependent, Supervision) or more
3. Mini-Mental State Examination score 24 or more

Key exclusion criteria 1. Walking speed less than 0.4m/sec in 10 meter walking test
2. Unable to understand verbal instructions due to aphasia or cognitive dysfunctions
3. Contraindications for encouragement to walk
-Conditions that need rest, i.e. acute phase of vertebral compression fracture, uncontrolled pain due to musculoskeletal diseases
-Respiratory and/or circulatory dysfunction that need restriction of activity
-Other conditions that need restriction of activity
4. Other conditions which physiatrists consider inappropriate to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Eri
Middle name
Last name Otaka
Organization Kariya Toyota General Hospital
Division name Department of Rehabilitation Medicine
Zip code 448-8505
Address 5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
TEL 0566-21-2450
Email eyokohama93@gmail.com

Public contact
Name of contact person
1st name Eri
Middle name
Last name Otaka
Organization Kariya Toyota General Hospital
Division name Department of Rehabilitation Medicine
Zip code 448-8505
Address 5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
TEL 0566-21-2450
Homepage URL
Email eyokohama93@gmail.com

Sponsor
Institute Kariya Toyota General Hospital
Institute
Department

Funding Source
Organization Kariya Toyota General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kariya Toyota General Hospital research ethics committee
Address 5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
Tel 0566-21-2450
Email KTGH.kouhou@toyota-kai.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 刈谷豊田総合病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 07 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 21 Day
Date of IRB
2017 Year 12 Month 21 Day
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 09 Day
Date trial data considered complete
2020 Year 04 Month 09 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 16 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036635

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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