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

Trial Summary

What is the purpose of this trial?

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 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).

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 data supports the effectiveness of the StrokeWear treatment for chronic stroke recovery?

Research shows that wearable sensors can help monitor and encourage movement in stroke patients, leading to increased use of the affected arm. Studies found that reminders from these devices can significantly boost arm activity, suggesting that StrokeWear could be a promising tool for improving motor recovery in stroke patients. ^{1 2 3 4 5}

How is the StrokeWear treatment different from other stroke recovery treatments?

StrokeWear is unique because it uses wearable technology to provide real-time feedback on motor performance, helping patients improve their movement and daily activities. This approach allows for personalized rehabilitation outside of clinical settings, which can be more convenient and adaptable to individual needs compared to traditional in-person therapies. ^{1 2 6 7 8}

Research Team

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Quantification of Movement in Stroke Patients under Free Living Conditions Using Wearable Sensors: A Systematic Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Understanding stroke survivors' preferences regarding wearable sensor feedback on functional movement: a mixed-methods study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Movement Reminders to Encourage Arm Use During Daily Life in Stroke Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Objective assessment of functional ambulation in adults with hemiplegia using ankle foot orthotics after stroke. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Prompting arm activity after stroke: A clinical proof of concept study of wrist-worn accelerometers with a vibrating alert function. [2022]

6. England pubmed.ncbi.nlm.nih.gov

'Regent Suit' training improves recovery of motor and daily living activities in subjects with subacute stroke: a randomized controlled trial. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Understanding preferences of stroke survivors for feedback provision about functional movement behavior from wearable sensors: a mixed-methods study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Virtual Arm Boot Camp (V-ABC): study protocol for a mixed-methods study to increase upper limb recovery after stroke with an intensive program coupled with a grasp count device. [2022]