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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Device: Wearable device -'Smart Reminder'; Other: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05878132

HSEARS20220704001

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Wearable device group

Experimental group

Description:

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.

Treatment:

Device: Wearable device -'Smart Reminder'

Conventional therapy group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional therapy