Wearable Sensors and Smartphone for Stroke

Overseen By Kathy Piela, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botulinum toxin

Disqualifiers: Cognitive impairments, Severe aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 93

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether wearable sensors and a smartphone app (mHealth technology) can help stroke survivors use their affected arm more in daily life. The study targets individuals who had a stroke over a year ago and still struggle with arm movement. Participants will wear sensors and use a custom app to track arm movement and receive feedback. The goal is to determine if this technology encourages better use of the stroke-affected arm. Ideal candidates are those who have had a stroke, can move their fingers and wrist to some extent, and regularly use smartphone apps. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance daily life for stroke survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, significant changes in your medication plan during the study that might affect arm use are not allowed.

What prior data suggests that this wearable sensor and smartphone method is safe for stroke survivors?

Research has shown that using smartphone apps and wearable sensors for stroke recovery is generally safe. Studies have found these mobile health tools easy for people to use. For example, smartphone technology helps stroke survivors with exercises at home by tracking progress and activity without risk.

The wearable sensors in these programs are designed to be comfortable and simple to use. Reports of negative effects are rare. Most participants find the technology helpful and easy to integrate into daily life.

Overall, current evidence suggests that mobile health tools in stroke recovery are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using wearable sensors and a smartphone app for stroke management because this approach leverages technology to provide real-time health monitoring and personalized feedback, which is a significant departure from traditional stroke rehabilitation methods that often involve in-person therapy sessions. Unlike standard treatments that require regular visits to healthcare facilities, this mHealth intervention allows for continuous monitoring and support at home, potentially improving convenience and adherence. Additionally, the ability to collect and analyze data remotely can offer more timely insights into a patient's recovery progress, enabling more dynamic and tailored interventions.

What evidence suggests that this mHealth intervention is effective for improving stroke-affected limb use?

Research has shown that mobile apps and wearable devices can help stroke survivors use their affected limbs more. In this trial, participants in the mHealth Intervention arm will receive wearable sensors and a smartphone application designed to aid in rehabilitation. One study found that increased use of therapy apps by stroke survivors led to better recovery. Wearable devices track important health information, such as movement and blood flow, which aids rehabilitation. While these tools show promise, researchers are still determining their effectiveness. The aim is to use technology to help stroke survivors use their affected limb more in daily life. ^{1 4 6 7 8}

Who Is on the Research Team?

Paolo Bonato, PhD

Principal Investigator

Director of Motion Analysis Laboratory

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors aged 18-80 with upper limb motor impairments who are more than 12 months post-stroke onset. Participants should be able to use a smartphone and wear sensors on their affected limb.

Inclusion Criteria

I can fully extend my fingers, thumb, and wrist.

Participants must be able to read, write, and understand English at a level sufficient to comprehend study materials and provide informed consent.

I survived a stroke and it's been over a year since.

Exclusion Criteria

I have not used botulinum toxin for motor issues in the last 3 months.

Cognitive impairments that may affect the ability to understand and follow instructions (score < 24 in the Mini Mental State Examination)

Previous participation in constraint-induced movement therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants wear wrist and index finger-worn sensors bilaterally for 14 days and self-annotate activities

2 weeks

Continuous monitoring with self-annotation every 90 minutes

Intervention

Participants interact with the Intervention app, receive feedback, and engage in Zoom calls with therapists

4 weeks

3 Zoom calls with research therapist

Retention

Participants continue wearing sensors without app feedback or clinician interactions to assess withdrawal effects

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the retention phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mHealth

Trial Overview The study tests if visual feedback from wearable sensors displayed on smartphones can increase the use of the stroke-affected arm in daily life. It's a self-controlled study where participants' activity levels before, during, and after using the app are compared.

How Is the Trial Designed?

Group I: mHealth Intervention Experimental Treatment 1 Intervention

Members of this group will receive the wearable sensors and mHealth smartphone application.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Published Research Related to This Trial

Wearable technology can significantly enhance stroke rehabilitation by providing objective assessments and monitoring of patients' progress both in clinical settings and at home, which can lead to more personalized therapy plans.

The review highlights the current use of various wearable sensors focused on upper extremity rehabilitation, discussing both the challenges faced in implementation and the opportunities for developing reliable tools to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. Maceira-Elvira, P., Popa, T., Schmid, AC., et al.[2020]

The SQUID smart shirt, which uses electromyography (EMG) and heart rate monitoring, offers a promising low-cost solution for remote rehabilitation of stroke patients, allowing for home-based therapy with real-time feedback.

Initial testing with a healthy subject demonstrated the system's ability to provide audiovisual and haptic feedback during exercises, indicating its potential for automated monitoring and support in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. Farjadian, AB., Sivak, ML., Mavroidis, C.[2017]

A qualitative study involving 17 physical therapists and 3 individuals with stroke identified key considerations for developing stroke-specific wearable monitoring technology, emphasizing the need for devices that accommodate the variability in patient needs and rehabilitation goals.

Stakeholders believe that such technology could significantly enhance rehabilitation practices, but it must include crucial design features and address barriers to adoption to be effectively integrated into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke. Louie, DR., Bird, ML., Menon, C., et al.[2020]

The Stroke Riskometer App was tested in a pilot study with 50 participants to assess its feasibility in improving stroke awareness and modifying risk behaviors, showing good retention at 87%.

While the App group showed a slight improvement in cardiovascular health compared to the control group, the results were not statistically significant, indicating the need for a larger trial to fully evaluate its effectiveness in primary stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial. Krishnamurthi, R., Hale, L., Barker-Collo, S., et al.[2023]

Smartphone apps can significantly improve the management of risk factors like hypertension and diabetes in stroke patients, which is crucial for preventing recurrent strokes, based on a review of 10 studies.

Patients generally find these mobile health apps useful and are receptive to using them, as long as they complement traditional medical care rather than replace it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of smartphone apps in secondary stroke prevention]. Fruhwirth, V., Enzinger, C., Weiss, E., et al.[2020]

Citations

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Effectiveness of mobile application interventions for stroke ... Our study suggested that mobile application interventions may have a potential benefit to stroke survivors, but clinical effectiveness should be established.

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At Home Wearable Sensors and Smartphone for Stroke ... The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during ...

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EngageHealth: a mobile device application designed to ... A recent study showed a positive association between time spent on therapy and clinical outcomes, with increased recovery among stroke survivors ...

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8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.125.050448

Digital Health in Low-Resource Settings: Comprehensive ... Mobile applications that guide patients through symptom tracking, physical activity monitoring, and medication adherence provide continuous data ...