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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Wearable device -'Smart Reminder'; Other: Conventional therapy

• Registration Number: NCT05878132
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Study First Submitted: 2023-04-03
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wearable device group	Wearable device -'Smart Reminder'	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.
Conventional therapy group	Conventional therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Motor Activity Log (MAL)	Change from baseline at 4 weeks	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 preintervention at 7-week (after crossover) Active range of motion (AROM) of shoulder and elbow	Change from 7-week at 11 weeks	The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.
Change from preintervention at 7-week (after crossover) Motor Activity Log (MAL)	Change from 7-week at 11 weeks	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 Fugl Meyer Upper Extremity assessment	Change from baseline at 4 weeks	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 Action Research Arm Test	Change from baseline at 4 weeks	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 preintervention at 7-week (after crossover) Action Research Arm Test	Change from 7-week at 11 weeks	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 Active range of motion (AROM) of shoulder and elbow	Change from baseline at 4 weeks	The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.
Change from preintervention at 7-week (after crossover) Fugl Meyer Upper Extremity assessment	Change from 7-week at 11 weeks	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)

Trial Locations

Locations (1)

Kenneth FONG; 🇭🇰 Hong Kong, Hong Kong