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

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

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.

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.