Clinical Trial: Effects of wearable device-based physical activity promotion in patients with stroke undergoing convalescent rehabilitation: a pilot randomized controlled trial (Japan)

Tokyo, June 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061758) titled 'Step-count feedback using a wearable device in patients with stroke undergoing convalescent rehabilitation' on June 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Hyogo Medical University

Condition: Condition - Patients with stroke undergoing rehabilitation in a convalescent rehabilitation ward Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 40

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070623

Disclaimer: Curated by HT Syndication.