UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041959 |
|---|---|
| Receipt number | R000047881 |
| Scientific Title | Efficacy of pedometer monitoring for stroke patients attending rehabilitation after discharge |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2022/08/11 05:29:41 |
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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
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
eyokohama93@gmail.com
Sponsor or person
Institute
Kariya Toyota General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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