Clinical trial NCT05877183: 'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device
Official title: 'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device to Provide Telerehabilitation for Persons With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Wearable Device
Keywords: wearable device
telerehabilitation
upper limb
Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.


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 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 .

Primary outcomes:
measure: Change from baseline: Fugl Meyer Upper Extremity assessment
timeFrame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
measure: Change from baseline: Action Research Arm Test (ARAT)
timeFrame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
measure: Change from baseline: Motor Activity Log (MAL)
timeFrame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
measure: Change from baseline: Muscle strength of the affected elbow and shoulder
timeFrame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
measure: Change from baseline: Active Range of motion of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
timeFrame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Secondary outcomes:
measure: Kinematic data of arm movement
timeFrame: Outcome measure will be evaluated post-treatment at 4 weeks.
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: 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.
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: Wei WXJ, Fong KNK, Chung RCK, Cheung HKY, Chow ESL. "Remind-to-Move" for Promoting Upper Extremity Recovery Using Wearable Devices in Subacute Stroke: A Multi-Center Randomized Controlled Study. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):51-59. doi: 10.1109/TNSRE.2018.2882235. Epub 2018 Nov 20.
citation: Wang Q, Markopoulos P, Yu B, Chen W, Timmermans A. Interactive wearable systems for upper body rehabilitation: a systematic review. J Neuroeng Rehabil. 2017 Mar 11;14(1):20. doi: 10.1186/s12984-017-0229-y.
citation: Rodgers MM, Alon G, Pai VM, Conroy RS. Wearable technologies for active living and rehabilitation: Current research challenges and future opportunities. J Rehabil Assist Technol Eng. 2019 Apr 26;6:2055668319839607. doi: 10.1177/2055668319839607. eCollection 2019 Jan-Dec.