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

Trial Summary

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 data supports the effectiveness of the StrokeWear System treatment for stroke?

Research shows that wearable sensors can help monitor stroke patients' movements in their daily lives, providing valuable information that complements traditional clinical evaluations. This suggests that the StrokeWear System, which likely uses similar technology, could be effective in assessing and aiding stroke recovery. ^{1 2 3 4 5}

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

The StrokeWear System is unique because it uses wearable technology, like sensorized garments, to monitor and assist in the rehabilitation of stroke patients by tracking their movements and providing real-time feedback, which is not typically available in standard stroke treatments. ^{6 7 8 9 10}

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 subacute 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).

Research Team

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Bespoke versus off-the-shelf ankle-foot orthosis for people with stroke: randomized controlled trial. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A Personalized Self-Management Rehabilitation System with an Intelligent Shoe for Stroke Survivors: A Realist Evaluation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Design of the user interface for "Stappy", a sensor-feedback system to facilitate walking in people after stroke: a user-centred approach. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Physical activity monitoring in stroke: SenseWear Pro2 activity accelerometer versus Yamax Digi-Walker SW-200 pedometer. [2022]

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

Daily-life monitoring of stroke survivors motor performance: the INTERACTION sensing system. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. [2019]

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

Posture classification via wearable strain sensors for neurological rehabilitation. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Development of User-Friendly Wearable Electronic Textiles for Healthcare Applications. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Relative contribution of footwear to the efficacy of ankle-foot orthoses. [2022]