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NCT Number: NCT05878132

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenneth FONG

Hong Kong, 000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline Fugl Meyer Upper Extremity assessment

    Time frame: Change from baseline at 4 weeks

    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)

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

    Time frame: Change from 7-week at 11 weeks

    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)

  3. Change from baseline Motor Activity Log (MAL)

    Time frame: Change from baseline at 4 weeks

    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)

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

    Time frame: Change from 7-week at 11 weeks

    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)

  5. Change from baseline Action Research Arm Test

    Time frame: Change from baseline at 4 weeks

    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).

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

    Time frame: Change from 7-week at 11 weeks

    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).

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

    Time frame: Change from baseline at 4 weeks

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

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

    Time frame: Change from 7-week at 11 weeks

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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2023
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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