'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke; Wearable Device

Treatments: Device: Sham device; Device: Wearable device -'Smart Reminder'

Study type: Interventional

Funder types: Other

Identifiers

NCT05877183

Smart reminder

Details and patient eligibility

About

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.

Enrollment: 40 estimated 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 score (FTHUE-HK) (Fong et al., 2004) between 3 to 6 (with a maximum score of 7)
• no complaint of excessive pain and swelling over the hemiplegic arm
• Modified Ashworth scale ≤ 2
• Mini-mental State Examination (MMSE) ≥ 19 (Wei et al., 2019)
• able to follow verbal instructions and 2-step commands in using the wearable device and smartphone.

Exclusion criteria

• participation in another similar form of experimental study during the same period,
• having a history of botulinum toxin injection in the past three months
• other significant upper limb impairment, i.e. fixed contractures, frozen shoulder and severe arthritis
• diagnosis which will interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment
• not fully vaccinated from COVID-19 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Wearable device group

Experimental group

Description:

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.

Treatment:

Device: Wearable device -'Smart Reminder'

Sham group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham device