Idle Time Exercise for Stroke Recovery

Overseen By Kim D Bassindale, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Disqualifiers: Concurrent illness, severe pain, others

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

Compensation: Varies

Number of Visits: 13

Duration: 3-12 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method to help stroke survivors use their affected arm more during recovery. It employs wearable technology to encourage therapeutic exercise, known as Idle Time Exercise, when patients are not engaged in other rehab activities. The trial seeks stroke survivors who experienced a stroke within the last 30 days and are currently in inpatient rehab at Froedtert Memorial Hospital in Milwaukee. Participants should have some arm movement issues but must be able to follow simple instructions. As an unphased trial, this study allows participants to contribute to innovative stroke recovery research using cutting-edge technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this wearable technology and associated procedures are safe for stroke recovery?

Research shows that exercise after a stroke is generally safe and can improve health. Studies indicate that light exercises, such as those in the Idle Time Exercise program, are usually safe and aid recovery. The American Stroke and Heart Association recommends regular physical activity for stroke survivors to support recovery. Although this specific trial lacks detailed safety data, past research suggests these exercises are well-tolerated and beneficial for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Idle Time Exercise for stroke recovery because it introduces a novel approach that differs from traditional therapies like physical therapy and medication. Unlike these standard treatments that require structured sessions or drug regimens, Idle Time Exercise can be seamlessly integrated into a patient's daily routine during periods of inactivity. This innovative technique leverages the brain's ability to rewire itself through consistent, low-effort movements, potentially enhancing recovery outcomes by encouraging more frequent exercise without the need for dedicated exercise periods. This approach aims to make rehabilitation more accessible and sustainable, which could lead to improved long-term recovery for stroke survivors.

What evidence suggests that this wearable technology and protocol are effective for stroke recovery?

Research shows that physical exercise can significantly aid recovery after a stroke. In this trial, participants will engage in Idle Time Exercise, focusing on exercises for the arms and hands. Previous studies have found these exercises lead to noticeable improvements over several weeks. Another study demonstrated that exercises improving heart and lung function during rehab assist with early recovery after a stroke. Additionally, increased physical activity was linked to better recovery six months post-stroke. These findings suggest that incorporating more movement into daily routines could enhance rehabilitation. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for stroke survivors currently in Froedtert Memorial Hospital's rehab unit, who had a stroke within the last month. Participants must be adults able to consent and follow instructions, with varying degrees of arm impairment as measured by the Fugl-Meyer Motor Assessment.

Inclusion Criteria

I had a stroke on one side of my brain within the last month.

My arm and hand movement is limited.

Ability to give informed consent and follow two-stage instructions

Exclusion Criteria

I can understand and follow basic instructions and can give informed consent.

I do not have any illness or severe pain that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 practice sessions using wearable technology to encourage arm movement post-stroke

3-12 days

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including interviews and device use at home

2 months

1 interview (virtual), 2 days of device use (home)

What Are the Treatments Tested in This Trial?

Interventions

• Idle Time Exercise

Trial Overview

The study tests if wearable technology can help increase use of the more-affected arm during early stroke recovery. It aims to encourage exercise during idle times without increasing clinician workloads, using mobile health approaches for personalized care.

How Is the Trial Designed?

Group I: Survivors of stroke in early stages of recovery Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

This study will assess the impact of feedback from a Smart watch on daily physical activity levels in stroke rehabilitation patients, with a focus on improving mobility and functional activities over a 3-week period.

Participants will be randomly assigned to receive either regular activity feedback or no feedback while wearing the Smart watch, allowing researchers to evaluate the effectiveness of feedback on enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. Dong, Y., Steins, D., Sun, S., et al.[2022]

A systematic review of 52 studies with 1928 stroke survivors found that interventions involving repetitive practice significantly improve muscle strength, with a standardized mean difference (SMD) of 0.25, indicating a moderate effect.

Improvements in strength from repetitive practice are also associated with enhanced activity levels, particularly in lower limb function (SMD of 0.25) and to a lesser extent in upper limb function (SMD of 0.15).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions involving repetitive practice improve strength after stroke: a systematic review. de Sousa, DG., Harvey, LA., Dorsch, S., et al.[2022]

Stroke is a major cause of disability, and currently, only 5-10% of stroke patients receive hyperacute revascularization procedures, highlighting the need for timely interventions.

Early prescribed exercise after a stroke can have significant long-term benefits, but there is a lack of guidelines for clinicians on how to safely implement these activities, necessitating a better understanding of the evidence and physiological principles involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. Bahouth, MN., Deluzio, S., Pruski, A., et al.[2023]

Progressive strength and low-intensity aerobic exercise programs lasting 3 to 6 months can significantly improve motor function, strength, balance, and overall fitness in stroke survivors without worsening spasticity.

Increasing access to community-based physical activity programs is crucial for preventing deconditioning and enhancing the quality of life for individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. Engardt, M., Grimby, G.[2017]

A scoping review of 13 studies involving 452 participants found that submaximal aerobic exercise testing protocols for individuals post-stroke can be safely implemented without serious adverse events, addressing concerns about cardiovascular risks.

The most common comorbidities among participants included hypertension (41%), diabetes (31%), and dyslipidemia (27%), indicating that these factors should be considered when designing exercise protocols for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. Legasto-Mulvale, JM., Inness, EL., Thompson, AN., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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Functional outcomes were significantly improved by 20 h of upper extremity-specific treatment over the course of four to six weeks.

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pmc.ncbi.nlm.nih.gov/articles/PMC3263535/

Physical Activity in the Prevention and Treatment of Stroke

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19 participants completed at least one day performing the easiest exercise, 18 progressed to the intermediate exercise, and 13 progressed to the most ...

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Idle Time Exercise for Stroke Recovery · Info for Participants

Research on exercise after stroke, including light-intensity exercises, suggests it is generally safe and can improve health without causing harm. Studies show ...