StrokeNCT05878132

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

A study testing Wearable device -'Smart Reminder' and Conventional therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Wearable device -'Smart Reminder' and Conventional therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteHong Kong
Study dates: 24 Aug 2022to 30 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Kenneth FONG
Hong Kong, 000000

Other trials in Hong Kong

About this study

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

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
Being tested: Wearable device -'Smart Reminder', Conventional therapy
Keywords: Stroke, telerehabilitation, Wearable device, Upper limb
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 therapyOther
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.

Study groups in NCT05878132
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from 7-week at 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202230 Dec 2022

First posted26 May 2023
Study start24 Aug 2022
Primary completion30 Dec 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Single-blinded randomized crossover trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05878132
Sponsor's protocol ID: HSEARS20220704001
Status last verified: May 2023
First submitted: 3 Apr 2023
Last updated: 26 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
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.
PubMed 7333761
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.
PubMed 17030751
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.
PubMed 1135616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05878132
Acronym / sponsor ID: HSEARS20220704001
Conditions: Stroke
Keywords: Stroke, telerehabilitation, Wearable device, Upper limb
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 24 Aug 2022 (actual)
Primary completion: 30 Dec 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 26 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single-blinded randomized crossover trial

Arm	Type	Receives
Wearable device group	Experimental	Device: Wearable device -'Smart Reminder'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.
Conventional therapy group	Active comparator	Other: Conventional therapyThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wearable device -'Smart Reminder'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.	Device	Wearable device group
Conventional therapyThe 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.	Other	Conventional therapy group

Primary outcome

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)
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)
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)
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)
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).
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).
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
BackgroundFong, 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: PubMed 7333761Lyle 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.
Background: PubMed 17030751Uswatte 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.
Background: PubMed 1135616Fugl-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wearable device -'Smart Reminder' and Conventional therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Fugl Meyer Upper Extremity assessment (time frame: Change from baseline at 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878132, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.