Clinical trial NCT05878132: 'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment
Official title: 'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment on the Hemiplegic Upper Limb in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
telerehabilitation
Wearable device
Upper limb
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blinded randomized crossover trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Fugl Meyer Upper Extremity assessment
timeFrame: Change from baseline at 4 weeks
measure: Change from preintervention at 7-week (after crossover) Fugl Meyer Upper Extremity assessment
timeFrame: Change from 7-week at 11 weeks
measure: Change from baseline Motor Activity Log (MAL)
timeFrame: Change from baseline at 4 weeks
measure: Change from preintervention at 7-week (after crossover) Motor Activity Log (MAL)
timeFrame: Change from 7-week at 11 weeks
measure: Change from baseline Action Research Arm Test
timeFrame: Change from baseline at 4 weeks
measure: Change from preintervention at 7-week (after crossover) Action Research Arm Test
timeFrame: Change from 7-week at 11 weeks
measure: Change from baseline Active range of motion (AROM) of shoulder and elbow
timeFrame: Change from baseline at 4 weeks
measure: Change from preintervention at 7-week (after crossover) Active range of motion (AROM) of shoulder and elbow
timeFrame: Change from 7-week at 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kenneth FONG
Study officials:
References:
citation: Fong, K., Ng, B., Chan, D., Chan, E., Ma, D., Au, B., ... & Occupational Therapy Central Coordinating Committee. (2004). Development of the Hong Kong version of the functional test for the hemiplegic upper extremity (FTHUE-HK). Hong Kong Journal of Occupational Therapy, 14(1), 21-29.
citation: Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
citation: Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.