An interventional study of Wearable device -'Smart Reminder' and Sham device in Stroke and Wearable Device, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Using wearable devices in the home setting allows continuous remote monitoring and feedback for intense self-directed training, an effective alternative to in-person rehabilitation. Emerging literature demonstrated that wearable devices are promising tools to enhance and deliver home-based upper limb training in stroke survivors. Nevertheless, previous reviews (Wang et al., 2017; Rodgers et al., 2019) highlighted a paucity of high-quality evidence concerning the clinical application of wearable devices in home-based rehabilitation.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Exclusion Criteria:
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.
Device: Wearable device -'Smart Reminder'
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.
Device: Sham device
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.
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.
Change from baseline: Fugl Meyer Upper Extremity assessment
The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements (Fugl, 1975). The total score is further subdivided into upper-extremity and hand subscores (Fugl, 1975).
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Action Research Arm Test (ARAT)
The ARAT is a frequently used assessment tool for hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and it has a total score of 57 (Lyle, 1981).
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Motor Activity Log (MAL)
The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily (Uswatte, Taub, Morris, Light, \& Thompson, 2006). It included two subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte et al., 2006).
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Muscle strength of the affected elbow and shoulder
The muscle strength of the affected elbow and shoulder will be measured using a force gauge.
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Active Range of motion of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
A digital goniometer will be used to evaluate the active ROM of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Kinematic data of arm movement
The wristwatch's built-in accelerometer will record the kinematic data of arm movements. This kinematic data referred to the mean acceleration in the X, Y, and Z directions over the 3-hour wearing period daily (Wei et al., 2019). The amount of arm movements is calculated using the ratio of the total number of movements divided by the total wearing duration (Wei et al., 2019).
Time frame: Outcome measure will be evaluated post-treatment at 4 weeks.
Plan to share: No
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The Hong Kong Polytechnic University