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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043762
Receipt No. R000049957
Scientific Title Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/27

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Basic information
Public title Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Acronym Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Scientific Title Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Scientific Title:Acronym Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Region
Japan

Condition
Condition cerebral vascular disease
Classification by specialty
Neurosurgery Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of goal setting for increasing physical activity in chronic stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of physical activity(Sitting time, standing time, walking time, number of transitions from sitting to standing)
Key secondary outcomes Vitality Index
SCI Exercise Self-Efficacy Scale
Kessler Psychological Distress Scale
Multidimensional Health Locus of Control scales
EQ-5D-5L
Functional Ambulation Classification
Gait speed
6 Minute Walk Test

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 In addition to the usual individual functional training, a 10 minute period is set aside to provide feedback on the amount of physical activity of each subject and to set additional goals for the amount of physical activity.The intervention period is 2 weeks.
Interventions/Control_2 In addition to the usual individual functional training, a 10 minute period is set aside to practice rising movements and to provide additional instruction on rising movements as self-training.The intervention period is 2 weeks.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients who use day-care rehabilitation
Key exclusion criteria Those who have difficulty in walking even with assistance.
Severe higher brain dysfunction, cognitive decline (MMSE score of 23 or below).
Those who have difficulty in listening by questionnaire.
Those who are judged by the physician to be inappropriate for participation in the study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Mitsutaka
Middle name
Last name Shibuya
Organization Hashimoto Hospital
Division name Hashimoto Rehabilitation Clinic Rehabilitation Dept
Zip code 770-0813
Address 3-19-3 Nakajousanjima-cho,Tokushima-city,Tokushima
TEL 088-626-0311
Email mttk.0317@gmail.com

Public contact
Name of contact person
1st name Mitsutaka
Middle name
Last name Shibuya
Organization Hashimoto Hospital
Division name Hashimoto Rehabilitation Clinic Rehabilitation Dept
Zip code 770-0813
Address 3-19-3 Nakajousanjima-cho,Tokushima-city,Tokushima
TEL 088-626-0311
Homepage URL
Email mttk.0317@gmail.com

Sponsor
Institute Hashimoto Hospital
Institute
Department

Funding Source
Organization None
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 The Ethics Committee of Kibi International University for Research Screening
Address 8 Iga-machi, Takahashi, Okayama prefecture
Tel 0866-22-9472
Email k_harada@kiui.ac.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 橋本リハビリテーションクリニック(徳島県)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 10 Day
Date of IRB
2021 Year 03 Month 17 Day
Anticipated trial start date
2021 Year 03 Month 31 Day
Last follow-up date
2022 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
2021 Year 03 Month 27 Day
Last modified on
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049957

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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