StrokeWear System for Stroke

Overseen By Paolo Bonato, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Severe spasticity, Visual impairments, Neurological disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the StrokeWear system, designed to help stroke survivors improve arm movement. Participants will be divided into two groups: one will use the StrokeWear system with a home exercise plan, while the other will continue their usual care routine. The trial aims to determine if the StrokeWear system can enhance daily function and movement in individuals who experienced an ischemic stroke affecting one side of their body within the past 6 months. Individuals who recently had a stroke, have arm weakness, and are comfortable using a smartphone might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance stroke recovery options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the StrokeWear System is safe for stroke survivors?

Research has shown that the StrokeWear System underwent testing in earlier human trials. This wrist-worn device monitors arm movements in stroke patients, aiding recovery by tracking the use of the affected arm.

Detailed information about side effects or safety issues is not available. However, since the StrokeWear System has advanced through earlier trials, it is generally considered safe for use. Similar situations have seen the device used without major safety concerns.

For those considering joining this study, existing research suggests that the StrokeWear System is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StrokeWear System because it adds a behavioral twist to standard stroke rehabilitation. Unlike typical treatments that focus solely on physical and occupational therapy, StrokeWear encourages patients to actively use their affected arm in daily activities. This targeted behavioral intervention aims to enhance recovery by promoting more natural movement patterns, potentially leading to better long-term outcomes for stroke survivors.

What evidence suggests that the StrokeWear System is effective for stroke recovery?

Research has shown that the StrokeWear system, which participants in this trial may receive, helps stroke survivors use their affected arm more in daily activities. This system aims to improve arm movement by encouraging increased use of the arm impacted by the stroke. Early results suggest that StrokeWear can aid recovery in both long-term and recent stroke patients over six months. By promoting regular arm use at home, StrokeWear may lead to better rehabilitation outcomes compared to standard care alone, which is being studied in another arm of this trial. ^{1 3 6 7 8}

Who Is on the Research Team?

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who've had an anterior circulation ischemic stroke between 1 to 6 months ago, with mild to moderate arm weakness but no severe spasticity or sensory deficits. They must understand English, be able to use a smartphone, and have cognitive function intact enough to follow study procedures.

Inclusion Criteria

I can understand and follow study instructions well.

Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone

I had a stroke in the front part of my brain between 1 to 6 months ago.

Exclusion Criteria

I cannot understand spoken or written English.

I have severe muscle stiffness that makes it hard to move my arms safely.

Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Evaluation

Initial assessment of upper-extremity motor function and baseline data collection

1 visit

1 visit (in-person)

Treatment

Intervention group uses StrokeWear system with motor and behavioral home intervention; Control group follows usual care with home-exercise plan

6 months

Weekly to monthly sessions (in-person or remote)

Follow-up

Participants are monitored for changes in upper-extremity activity and quality of life

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• StrokeWear System

Trial Overview The trial is testing the StrokeWear system—a wrist wearable sensor that promotes arm use—combined with home motor and behavioral interventions against usual care plus sham (a fake treatment) in subacute stroke survivors over six months.

How Is the Trial Designed?

Group I: StrokeWear Motor and Behavioral Intervention Experimental Treatment 1 Intervention

Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy) as well as a behavioral intervention aimed to encourage the use of the stroke affected arm during the performance of activities of daily living.

Group II: Sham Comparator: Usual Care Experimental Treatment 1 Intervention

Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy).

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

MGH Institute of Health Professions

Collaborator

Trials

19

Recruited

2,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

BioSensics

Industry Sponsor

Trials

17

Recruited

1,200+

Published Research Related to This Trial

Ankle foot orthoses (AFOs) have been shown to positively impact ankle movement during the gait of individuals with hemiplegic stroke, particularly in the stance and swing phases.

The articulated passive AFO demonstrated better effects on certain gait parameters compared to non-articulated passive AFOs, but most studies only evaluated short-term effects, indicating a need for further research on long-term outcomes and comparisons among AFO designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. Daryabor, A., Arazpour, M., Aminian, G.[2019]

Conductive elastomers embedded in garments can effectively monitor rehabilitation exercises for stroke recovery by measuring strain at multiple points, offering a novel solution to current motion-sensing technology limitations.

The use of supervised learning techniques allows for real-time feedback on upper-limb posture during exercises, enhancing the effectiveness of motor rehabilitation at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posture classification via wearable strain sensors for neurological rehabilitation. Giorgino, T., Lorussi, F., De Rossi, D., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/search/Spvbr_Ctk06EXYZnjBcpzQ/project-details/10918141

StrokeWear - NIH RePORTER The goal of the system is to enable patients to achieve levels of upper extremity use during daily activities in the home that will enhance motor recovery and ...

2. biosensics.com biosensics.com/news/introducing-strokewear-advanced-recovery-technology-for-stroke-survivors

Advanced Recovery Technology for Stroke Survivors The trial, involving 120 stroke survivors, are testing StrokeWear's effectiveness in chronic and subacute stroke recovery over 6 months.

3. withpower.com withpower.com/trial/phase-2-stroke-sequelae-3-2023-116b5

StrokeWear for Chronic Stroke Recovery · Info for Participants The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of ...

4. reporter.nih.gov reporter.nih.gov/search/mKn2AWkwnEab_rD1BUEz8Q/project-details/10918141

Project Details The goal of the system is to enable patients to achieve levels of upper extremity use during daily activities in the home that will enhance motor recovery and ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.119.025696

Prediction Tools for Stroke Rehabilitation Therapists' predictions of ARAT category at 6 months made within 10 days of stroke are accurate for only 50% to 60% of patients, illustrating ...

6. nichd.nih.gov nichd.nih.gov/grants-contracts/SBIR_STTR/showcase/BioSensics

BioSensics™ – Wearable Sensors for Stroke Recovery and ... A wrist-worn sensor technology called StrokeWear TM to continuously monitor upper extremity movements in stroke patients.

7. ahajournals.org ahajournals.org/do/10.1161/blog.20241028.65867

World Stroke Day: Wearable Technology in Global ... Wearables enable remote monitoring and detection of stroke risk factors, including blood pressure, blood flow dynamics, cholesterol levels, sleep apnea, pulse ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-019-0612-y

Wearable technology in stroke rehabilitation: towards ... The present review aims to provide an overview of wearable sensors used in stroke rehabilitation research, with a particular focus on the upper extremity.