'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device
NCT ID: NCT05877183
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-06-01
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study examines the effectiveness of the enhanced version of the wearable device as a home-based upper limb rehabilitation intervention to improve the hemiplegic upper limb motor function of persons with stroke. The study seeks to address the research question:
'Is wearable device intervention in the home more effective in promoting arm recovery in stroke survivors than conventional therapy with a sham device after treatment and follow-up?' We hypothesize that the multimodal feedback system and improved features from the wearable device will provide a more effective and sustainable treatment option than conventional therapy with a sham device to promote the motor recovery of the hemiplegic UL function in persons with stroke.
A parallel single-blinded randomized controlled trial will be conducted in Hong Kong hospital outpatient and/or community stroke service settings. There will be two study groups: (1) a wearable device group and (2) a sham group. Forty participants will be randomly allocated into any of the two study groups (1) the experimental (wearable device) group and (2) the sham group (use the pictorial handout and sham device) using a computer-generated random number sequence to conceal the allocation.
Participants in the experimental group will undergo a 4-week wearable device treatment and participants in the sham group will receive a sham device and complete a 4-week conventional training. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, and follow-up at 8-week by blinded assessors.
The results of this study will show the possible efficacy of the wristwatch device in promoting motor recovery of the hemiplegic upper limb in stroke survivors and pave the way for an alternative stroke therapy that uses novel wearable technology in the home setting.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment
NCT05878132
"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
NCT02952677
The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
NCT02587585
Promoting Neuroplastic Changes of Patients With TBI
NCT06465290
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
NCT06797154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Wearable device group
Participants will be instructed to wear the wristwatch for a minimum of 3 hours per day, 5 days per week and engage in telerehabilitation, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation.
Wearable device -'Smart Reminder'
The wearable device, a wristwatch, has a Bluetooth function to link to mobile devices for the participants to view the prescribed videos and engage in telerehabilitation. It has sensors to monitor arm movements and provides multiple feedbacks (auditory, visual and tactile). Participants were instructed to practice the prescribed exercises -tailored according to the severity of UL paresis for the recommended therapy dose. The device recorded the angles of arm movement and the number of repetitions completed and data collected is uploaded to an encrypted cloud server for remote monitoring. Weekly, the participants will receive a 45-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data.
Sham group
The participants will be instructed to wear the sham device for a minimum of 3 hours per day, 5 days per week. In addition, they will be instructed to engage in upper limb training with the prescribed exercises presented in the form of a pictorial handout rather than an in-app video, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation.
Sham device
The sham device is also a wristwatch, which consists of an accelerometer, a gyroscope sensor, and a rechargeable battery that supports up to 72 hours of continuous use. The device will monitor the participant's arm activity, but it will not emit any reminders or be connected to a telerehabilitation system. The participants were instructed to perform the exercises from the pictorial handout for the recommended therapy dose and received a weekly therapy consultation as well.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Wearable device -'Smart Reminder'
The wearable device, a wristwatch, has a Bluetooth function to link to mobile devices for the participants to view the prescribed videos and engage in telerehabilitation. It has sensors to monitor arm movements and provides multiple feedbacks (auditory, visual and tactile). Participants were instructed to practice the prescribed exercises -tailored according to the severity of UL paresis for the recommended therapy dose. The device recorded the angles of arm movement and the number of repetitions completed and data collected is uploaded to an encrypted cloud server for remote monitoring. Weekly, the participants will receive a 45-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data.
Sham device
The sham device is also a wristwatch, which consists of an accelerometer, a gyroscope sensor, and a rechargeable battery that supports up to 72 hours of continuous use. The device will monitor the participant's arm activity, but it will not emit any reminders or be connected to a telerehabilitation system. The participants were instructed to perform the exercises from the pictorial handout for the recommended therapy dose and received a weekly therapy consultation as well.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* unilateral hemispherical involvement
* diagnosis of stroke with onset ≥ three months
* hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version score (FTHUE-HK) (Fong et al., 2004) between 3 to 6 (with a maximum score of 7)
* no complaint of excessive pain and swelling over the hemiplegic arm
* Modified Ashworth scale ≤ 2
* Mini-mental State Examination (MMSE) ≥ 19 (Wei et al., 2019)
* able to follow verbal instructions and 2-step commands in using the wearable device and smartphone.
Exclusion Criteria
* having a history of botulinum toxin injection in the past three months
* other significant upper limb impairment, i.e. fixed contractures, frozen shoulder and severe arthritis
* diagnosis which will interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment
* not fully vaccinated from COVID-19 .
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hong Kong Polytechnic University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kenneth N. K. Fong
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kenneth FONG
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Fong, K., Ng, B., Chan, D., Chan, E., Ma, D., Au, B., ... & Occupational Therapy Central Coordinating Committee. (2004). Development of the Hong Kong version of the functional test for the hemiplegic upper extremity (FTHUE-HK). Hong Kong Journal of Occupational Therapy, 14(1), 21-29.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
Wei WXJ, Fong KNK, Chung RCK, Cheung HKY, Chow ESL. "Remind-to-Move" for Promoting Upper Extremity Recovery Using Wearable Devices in Subacute Stroke: A Multi-Center Randomized Controlled Study. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):51-59. doi: 10.1109/TNSRE.2018.2882235. Epub 2018 Nov 20.
Wang Q, Markopoulos P, Yu B, Chen W, Timmermans A. Interactive wearable systems for upper body rehabilitation: a systematic review. J Neuroeng Rehabil. 2017 Mar 11;14(1):20. doi: 10.1186/s12984-017-0229-y.
Rodgers MM, Alon G, Pai VM, Conroy RS. Wearable technologies for active living and rehabilitation: Current research challenges and future opportunities. J Rehabil Assist Technol Eng. 2019 Apr 26;6:2055668319839607. doi: 10.1177/2055668319839607. eCollection 2019 Jan-Dec.
Toh FM, Lam WWT, Cruz Gonzalez P, Fong KNK. Effects of a Wearable-Based Intervention on the Hemiparetic Upper Limb in Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Jan;39(1):31-46. doi: 10.1177/15459683241283412. Epub 2024 Sep 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Smart reminder
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.