StrokeWear for Chronic Stroke Recovery

Overseen By Paolo Bonato, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botox

Disqualifiers: Severe spasticity, Visual impairments, Others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the StrokeWear system aids stroke recovery. It will compare two groups: one using StrokeWear with a specialized motor and behavior program, and the other performing regular home exercises. The goal is to determine if StrokeWear enhances daily living activities for stroke survivors. Individuals who experienced a stroke between 6 months and 5 years ago, have difficulty moving one arm, and can use a smartphone or tablet may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in stroke recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that the StrokeWear system is safe for chronic stroke recovery?

Research has shown that the StrokeWear system, which combines wearable technology with exercises and activities, aims to help stroke survivors use their affected arm more in daily life. Understanding the safety of this treatment is crucial. Unfortunately, direct safety information on this specific treatment remains limited.

As a Phase 2 trial, some evidence from earlier studies suggests the treatment might be safe, but further research is necessary to confirm this. Phase 2 trials typically focus on determining the best dose while monitoring for side effects. If any serious safety issues had been identified earlier, the treatment likely would not have advanced to this phase.

In summary, while clear safety data for StrokeWear is lacking, its testing in a Phase 2 trial indicates that initial findings were promising enough to proceed. Participants in these trials receive close monitoring to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the StrokeWear Motor and Behavioral Intervention because it adds a unique layer to traditional stroke recovery methods. Unlike standard care, which includes occupational and physical therapy, this treatment incorporates a behavioral intervention that encourages stroke survivors to actively use their affected arm during daily activities. This approach aims to enhance recovery by promoting greater engagement and use of the impaired limb, potentially leading to improved functional outcomes. By focusing on real-world application and involvement, StrokeWear offers a promising avenue for enhancing rehabilitation beyond what conventional therapies can achieve.

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

In this trial, researchers will divide participants into two groups. One group will receive the StrokeWear Motor and Behavioral Intervention, which earlier studies have shown to help stroke survivors improve arm movement. Research indicates that thorough rehabilitation programs, such as those using StrokeWear, play a crucial role in recovery after a stroke. This system encourages the use of the affected arm in everyday activities, potentially aiding recovery. The other group will receive Usual Care, which focuses on standard occupational and physical therapy. Early results suggest that focused interventions like StrokeWear could enhance arm movement over time, aiming to improve the overall recovery experience for those living with long-term effects of a stroke. ^{1 2 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 chronic stroke survivors aged 18-85 with mild to moderate arm weakness from a stroke that happened between 6 months and 5 years ago. They must be able to understand the study, use a tablet or smartphone, and not have severe spasticity, visual impairments preventing app use, other neurological diseases, severe proprioceptive deficits, recent fractures or wounds in the affected arm, current enrollment in another upper extremity rehab program.

Inclusion Criteria

I had a stroke affecting the front part of my brain between 6 months and 5 years ago.

I can understand and follow study instructions well.

Being familiar and comfortable with the use of a tablet or smartphone

Exclusion Criteria

I am currently in a rehabilitation program for my upper extremity.

Criterion: You have to have good vision and not have trouble seeing things on the screen.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Evaluation

Baseline evaluation of upper-extremity motor function and other assessments

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) based on group and phase

Follow-up Evaluation

Evaluation visits at 3 months and 6 months to assess clinical outcomes

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StrokeWear Motor and Behavioral Intervention
• Usual Care

Trial Overview The trial is testing StrokeWear system combined with home motor and behavioral interventions against usual care involving a home-exercise plan. Participants are randomly placed into either group for six months to see if StrokeWear improves their ability to use their affected arm in daily life.

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 occupational and physical therapy in addition to a behavioral intervention aimed to encourage stroke survivors to use their affect arm during the performance of activities of daily living.

Group II: Usual Care Placebo Group 1 Intervention

Stroke survivors randomized to this group will receive standard occupational and physical 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

In a study involving 13 participants who had experienced a unilateral ischemic stroke, wearable sensors that provided vibrotactile reminders significantly increased the use of the affected arm after reminders were given.

The positive effect of these reminders on arm activity was sustained throughout the day and over a 6-week home intervention period, suggesting that this approach could be an effective rehabilitation tool for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement Reminders to Encourage Arm Use During Daily Life in Stroke Patients. Mayrhuber, L., Lestoille, M., Andres, SD., et al.[2023]

Citations

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

StrokeWear - NIH RePORTER We will conduct two 6-month randomized clinical trials to assess the efficacy of this integrated platform in both chronic and subacute stroke survivors. The ...

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

StrokeWear for Chronic Stroke Recovery · Info for Participants Trial Overview The trial is testing StrokeWear system combined with home motor and behavioral interventions against usual care involving a home-exercise plan.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X24004775

Upper-extremity motor recovery after stroke: A systematic ... This systematic review and meta-analysis aimed to assess rate and amount of recovery of UE with UC in the subacute phase of stroke and identify covariates of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10608684/

Stroke Recovery Is a Journey: Prediction and Potentials of ... A comprehensive rehabilitation program is essential for stroke recovery. A standard motor rehabilitation program involves physical therapy and ...

5. ahajournals.org ahajournals.org/doi/10.1161/circoutcomes.115.002098

Chronic Stroke Outcome Measures for Motor Function ... We identified 115 clinical trials of interventions to improve motor function in patients with chronic stroke; 55 of those looked at lower ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10621082/

Understanding stroke survivors' preferences regarding ... Feedback based on wearable sensor data can encourage health-promoting behaviors for stroke survivors, such as physical activity and the choice ...

7. pnas.org pnas.org/doi/10.1073/pnas.2026676118

Critical Period After Stroke Study (CPASS): A phase II ... The primary outcome measure was ARAT recovery over 1 y after stroke. By 1 y we found significantly increased UE motor function in the subacute ...

8. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2023.1205063/full

Prediction of rehabilitation induced motor recovery after ... This article introduces the cross-modality protocols designed to investigate the rehabilitation treatment's effect in a group of stroke survivors.