'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment

Study Overview
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Brief Summary
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This pilot study examines the feasibility and potential effects on upper limb (UL) motor function using a wearable device integrated with a telerehabilitation function in the home setting with chronic stroke survivors. The study seeks to address the question: - Is wearable device intervention more effective in promoting arm recovery in stroke survivors than conventional therapy for home-based training? We hypothesize that using a multimodal feedback system in the wearable device can provide more effective training to improve the hemiplegic UL function of chronic stroke survivors than conventional therapy. This is a single-blinded randomized crossover pilot trial. Twelve participants will be randomly assigned into two groups: the experimental (wristwatch) and the control (conventional therapy) groups. Participants in the experimental group will undergo a 4-week wearable device treatment followed by a 4-week conventional training. Participants in the control group will complete conventional therapy and then wearable device treatment. There will be a 3-week washout period between treatments. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, after a 3-week washout period for pre-intervention, and post-intervention after crossover by research assistants blinded to group allocation.

Official Title
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'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment on the Hemiplegic Upper Limb in Persons With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Wearable device -'Smart Reminder'
* Other: Conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years unilateral hemispherical involvement diagnosis of stroke with onset ≥ three months hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version (FTHUE-HK) ≥ score of 3 (maximum of 7) (Fong et al., 2004). no complaint of excessive pain and swelling over the hemiplegic arm able to provide informed consent to participate. Exclusion Criteria: participating in another similar form of experimental study during the same period having a history of botulinum toxin injection in the past three months having other significant upper limb impairment, i.e. fixed contractures, frozen shoulder, and severe arthritis having a diagnosis which would interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-blinded randomized crossover trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable device group<br>Participants in the experimental group will be instructed to wear the wristwatch device five days per week for a minimum of 3 hours per day and engage in telerehabilitation, 1hour per day for 5 times per week over 4 weeks. Weekly, there will be a 30-minute therapy consultation. | Device: Wearable device -'Smart Reminder'<br>* 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 30-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data.<br>|
| Active Comparator: Conventional therapy group<br>The participants in the conventional group will receive similar in-home upper limb exercises as the wearable device group, with the prescribed exercises presented in the form of a pictorial handout rather than an in-app video. They are instructed to perform the exercises 1hour per day, 5times per week over 4 weeks. Weekly, there will be a 30-minute therapy consultation. | Other: Conventional therapy<br>* The participants in the control group received similar in-home upper limb exercises as the wearable device group, with the prescribed exercises presented in the form of a pictorial handout rather than an in-app video. They were instructed to perform the exercises for the recommended therapy dose and received a weekly therapy consultation as well. To monitor the participant's exercise compliance, they were instructed to record their daily exercise progress in the exercise log.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975) | Change from baseline at 4 weeks | 
| Change from preintervention at 7-week (after crossover) 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.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975) | Change from 7-week at 11 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. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light & Thompson, 2006) | Change from baseline at 4 weeks | 
| Change from preintervention at 7-week (after crossover) Motor Activity Log (MAL) | The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light & Thompson, 2006) | Change from 7-week at 11 weeks | 
| Change from baseline Action Research Arm Test | The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981). | Change from baseline at 4 weeks | 
| Change from preintervention at 7-week (after crossover) Action Research Arm Test | The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981). | Change from 7-week at 11 weeks | 
| Change from baseline Active range of motion (AROM) of shoulder and elbow | The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer. | Change from baseline at 4 weeks | 
| Change from preintervention at 7-week (after crossover) Active range of motion (AROM) of shoulder and elbow | The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer. | Change from 7-week at 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, telerehabilitation, Wearable device, Upper limb