UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061758 |
|---|---|
| Receipt number | R000070623 |
| Scientific Title | Effects of wearable device-based physical activity promotion in patients with stroke undergoing convalescent rehabilitation: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/06/01 08:02:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Step-count feedback using a wearable device in patients with stroke undergoing convalescent rehabilitation
Acronym
ActivePAS-Step pilot study
Scientific Title
Effects of wearable device-based physical activity promotion in patients with stroke undergoing convalescent rehabilitation: a pilot randomized controlled trial
Scientific Title:Acronym
ActivePAS-Step pilot study
Region
| Japan |
Condition
Condition
Patients with stroke undergoing rehabilitation in a convalescent rehabilitation ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to preliminarily examine the effects of step-count feedback based on physical activity monitoring using a wearable device on physical activity in patients with stroke admitted to a convalescent rehabilitation ward.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity at 2 to 4 weeks after the start of the intervention
Physical activity at 6 months after the start of the intervention
Key secondary outcomes
Adverse events during the intervention period
Adverse events during the follow-up period
Walking ability at 2 to 4 weeks after the intervention, including 10-meter walk time and 6-minute walk distance
Physical function at 2 to 4 weeks after the intervention, including the modified Rankin Scale and Short Physical Performance Battery
Activities of daily living at 2 to 4 weeks after the intervention, assessed using the Functional Independence Measure
Self-efficacy for physical activity at 2 to 4 weeks and 6 months after the start of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
In the intervention group, participants receive usual rehabilitation-based care plus feedback on step counts measured using a wearable device. The physical therapist provides feedback on daily and weekly step-count goals according to each participant's condition. The wearable device is placed in a dedicated belt pouch and worn around the waist, except during bathing and changing clothes. The intervention period ranges from 2 to 4 weeks.
Interventions/Control_2
In the control group, participants wear the same wearable device as those in the intervention group, but neither the participants nor healthcare professionals can access the physical activity data during the measurement period. Participants continue usual rehabilitation. If requested, the physical therapist provides feedback on physical activity after the measurement period during usual rehabilitation. The observation period ranges from 2 to 4 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older
2. Patients with a Functional Independence Measure locomotion score of 4 or higher
3. Patients with a walking speed of 0.8 m/sec or higher
4. Patients who provide written informed consent after receiving an explanation of the study
Key exclusion criteria
1. Patients with subarachnoid hemorrhage
2. Patients expected to be hospitalized for less than 2 weeks
3. Patients with a pre-stroke modified Rankin Scale score of 3 or higher
4. Patients with stroke occurring as a perioperative complication of cardiovascular surgery
5. Patients with neurological, orthopedic, or internal diseases other than stroke that seriously affect physical activity
6. Patients suspected of having obvious cognitive impairment, defined as a Mini-Mental State Examination score of 21 or lower
7. Patients who cannot provide consent for study participation by themselves
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy, School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe 650-8530, Hyogo, Japan
TEL
078-304-313
nozoe-m@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy, School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe 650-8530, Hyogo, Japan
TEL
078-304-313
Homepage URL
nozoe-m@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aijinkai Rehabilitation Hospital, Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan
Tel
0798-45-6066
rinri@hyo-med.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
愛仁会リハビリテーション病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070623
