UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of pedometer monitoring for stroke patients attending rehabilitation after discharge
Acronym	Efficacy of pedometer monitoring for stroke after discharge
Scientific Title	Efficacy of pedometer monitoring for stroke patients attending rehabilitation after discharge
Scientific Title:Acronym	Efficacy of pedometer monitoring for stroke after discharge
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy of pedometer-based feedback on walking ability in patients with stroke attending rehabilitation after discharge.
Basic objectives2	Others
Basic objectives -Others	To assess changes in physical activity after discharge from convalescent rehabilitation ward in patients with stroke by using pedometer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in six minutes walking distance 3 months after intervention and 6 months after quitting intervention
Key secondary outcomes	changes in ten meter walking speed, Timed Up&Go Test, Timed single leg stance, grip strength, Life space Assessment 3 months after intervention and 6 months after quitting intervention

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Participants wear a pedometer on the ankle of the unaffected side and start step count monitoring 1 week before discharge from a convalescent rehabilitation ward. After discharge, step counts are monitored for the first 3 weeks in advance of intervention while attending standard rehabilitation program for daycare facility (therapist intervention 40 minutes+self exercise 40 minutes/day, 1-2 times/week, 3 months). Afterward, participants receive feedback on pedometer data and personalized advice for increasing step count once a week, for 9 weeks.
Interventions/Control_2
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. within 1 year after stroke onset 2. Functional Ambulation Category 4 (Independent, Level Surfaces Only) or more 3. able to understand instructions for intervention and consent to participate in the study
Key exclusion criteria	1. Walking speed less than 0.4m/sec in 10 meter walking test 2. Unable to understand instructions due to aphasia or cognitive dysfunctions 3. Contraindications for encouragement to walk -Conditions that need rest for treatment, i.e. uncontrolled pain due to musculoskeletal diseases -Respiratory and/or circulatory dysfunction that need restriction of activity -Other conditions that need restriction of activity
Target sample size	10

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
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	2020 Year 09 Month 30 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	Terminated
Date of protocol fixation	2020 Year 09 Month 15 Day
Date of IRB	2020 Year 09 Month 15 Day
Anticipated trial start date	2020 Year 09 Month 23 Day
Last follow-up date	2021 Year 12 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 09 Month 30 Day
Last modified on	2022 Year 08 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047881