Step-count feedback using a wearable device in patients with stroke undergoing convalescent rehabilitation

Effects of wearable device-based physical activity promotion in patients with stroke undergoing convalescent rehabilitation: a pilot randomized controlled trial - ActivePAS-Step pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061758

Enrollment

Registered

2026-06-01

Start date

2026-05-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with stroke undergoing rehabilitation in a convalescent rehabilitation ward

Interventions

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 wee

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. In the con

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Physical activity at 2 to 4 weeks after the start of the intervention Physical activity at 6 months after the start of the intervention	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMasafumi Nozoe

Hyogo Medical University Department of Physical Therapy, School of Rehabilitation

nozoe-m@hyo-med.ac.jp078-304-313

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026