UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046731 |
|---|---|
| Receipt number | R000053315 |
| Scientific Title | Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: a pilot randomized controlled study |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/04/09 20:06:45 |
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Basic information
Public title
Effects of wearable device on physical activity promotion in patients with stroke undergoing rehabilitation
Acronym
ActivePAS pilot study
Scientific Title
Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: a pilot randomized controlled study
Scientific Title:Acronym
ActivePAS pilot study
Region
| Japan |
Condition
Condition
Patients with stroke undergoing rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and feasibility of a multidisciplinary intervention that promotes physical activity in stroke patients undergoing rehabilitation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (adverse events: falls, fractures or trauma requiring treatment, neurological deterioration)
Feasibility (rate of wearing wearable device, completion rate of the intervention, percentage of participants who meet the eligibility criteria)
Key secondary outcomes
Physical activity
Walking speed
Short Physical Performance Battery
Six-minute walk distance
Functional Independence Measure motor function
Self-efficacy for physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: In addition to regular rehabilitation, the participants in the intervention group are instructed in self-monitoring of their physical activity. Moreover, multidisciplinary medical staffs monitor the amount of physical activity of the participants and provide advice on how to promote physical activity in daily life.
Interventions/Control_2
Control group: Usual rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients hospitalized for stroke
2) Patients who able to walk 50m with at least hand assistance
3) Aged 20 years or older
Key exclusion criteria
Patients with subarachnoid hemorrhage
Stroke after cardiovascular surgery
Those who are expected to be hospitalized for less than 2 weeks
Those who have a modified Rankin Scale of 3 or higher before stroke
Those who have neurological, orthopedic, or medical diseases other than stroke that seriously affect physical activity
Those who are suspected to have obvious cognitive impairment
Those who cannot give consent for research participation
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Konan Women's University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
078-413-3584
nozoe@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kanai |
Organization
Konan Women's University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
078-413-3648
Homepage URL
kanai@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kitasato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishi-Kinen Port Island Rehabilitation Hospital
Address
8-5-2, Minatojimanakamachi, Chuo-ku, Kobe, Hyogo
Tel
078-303-2424
nmpr-riha@koyukai.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
西記念ポートアイランドリハビリテーション病院 （兵庫県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053315
