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

NCT05878132 | Completed

• 1 other identifier: HSEARS20220704001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; telerehabilitation; Wearable device; Upper limb

Outcome Measures

Primary Outcomes (8)

• Change from baseline Fugl Meyer Upper Extremity assessment

  The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975)

  Change from baseline at 4 weeks

• Change from preintervention at 7-week (after crossover) Fugl Meyer Upper Extremity assessment

  The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975)

  Change from 7-week at 11 weeks

• Change from baseline Motor Activity Log (MAL)

  The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light \& Thompson, 2006)

  Change from baseline at 4 weeks

• Change from preintervention at 7-week (after crossover) Motor Activity Log (MAL)

  The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light \& Thompson, 2006)

  Change from 7-week at 11 weeks

• Change from baseline Action Research Arm Test

  The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981).

  Change from baseline at 4 weeks

• Change from preintervention at 7-week (after crossover) Action Research Arm Test

  The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981).

  Change from 7-week at 11 weeks

• Change from baseline Active range of motion (AROM) of shoulder and elbow

  The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.

  Change from baseline at 4 weeks

• Change from preintervention at 7-week (after crossover) Active range of motion (AROM) of shoulder and elbow

  The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.

  Change from 7-week at 11 weeks

Study Arms (2)

Wearable device group

EXPERIMENTAL

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.

Device: Wearable device -'Smart Reminder'

Conventional therapy group

ACTIVE COMPARATOR

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.

Other: Conventional therapy

Interventions

Wearable device -'Smart Reminder' DEVICE

The wearable device, a wristwatch, has a Bluetooth function to link to mobile devices for the participants to view the prescribed videos and engage in telerehabilitation. It has sensors to monitor arm movements and provides multiple feedbacks (auditory, visual and tactile). Participants were instructed to practice the prescribed exercises -tailored according to the severity of UL paresis for the recommended therapy dose. The device recorded the angles of arm movement and the number of repetitions completed and data collected is uploaded to an encrypted cloud server for remote monitoring. Weekly, the participants will receive a 30-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data.

Wearable device group

Conventional therapy OTHER

The participants in the control group received 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 were instructed to perform the exercises for the recommended therapy dose and received a weekly therapy consultation as well. To monitor the participant's exercise compliance, they were instructed to record their daily exercise progress in the exercise log.

Conventional therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Kenneth FONG

Hong Kong, 000000, Hong Kong

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 7333761 BACKGROUND

• 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.

  PMID: 17030751 BACKGROUND

• 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.

  PMID: 1135616 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization was stratified based on the participant's baseline upper limb severity according to the FTHUE-HK. Masking to treatment allocation for therapist and participants was not feasible. Only the outcome assessor was blinded to the treatment allocation and participants were instructed not to tell the assessor their group allocation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blinded randomized crossover trial

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 26, 2023
• Study Start: August 24, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)