What side effects are associated with this type of intervention?

Common treatments for stroke, particularly those involving motor rehabilitation such as robot-assisted therapy with force-feedback robots, generally aim to improve motor function and reduce disability. Known side effects of these treatments can include muscle soreness, fatigue, and, in some cases, joint pain due to repetitive movements. Additionally, there may be a risk of skin irritation or pressure sores from prolonged use of robotic devices. However, these side effects are typically mild and temporary, and the benefits of improved motor function often outweigh these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on clot-dissolving medications like tissue plasminogen activator (tPA) and mechanical thrombectomy devices for acute ischemic stroke. For motor rehabilitation, while specific FDA approvals for robot-assisted therapy systems like the Rehab CARES system are not detailed, there has been significant interest and research in robotic and force-feedback technologies to aid in motor recovery post-stroke. These technologies aim to enhance traditional physical therapy by providing precise, repetitive, and adaptive movements to improve motor function.

What other types of research exist?

Promising, novel alternatives to Robot-Assisted Therapy with the Rehab CARES System for stroke patients in 2024 include: 1) Non-invasive brain stimulation techniques such as Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), which have shown potential in enhancing motor recovery. 2) Virtual Reality (VR) therapy, which provides immersive environments for motor skill practice and has been effective in improving motor function. 3) Advanced physical therapy techniques like Constraint-Induced Movement Therapy (CIMT) and task-specific training, which focus on intensive, repetitive use of the affected limb to promote neuroplasticity and functional recovery.

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Robot-Assisted Therapy for Stroke

N/A

Recruiting

Led By Michelle J Johnson, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stroke diagnosis

Upper arm manual muscle strength scores >1

Must not have

Severe cognitive function

No cerebellum lesions due to stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

Summary

This trial is testing a new rehabilitation method for stroke patients using simple robots that help with exercises. The robots provide feedback and can be used alone or in groups to play therapy games. The goal is to see if this method is as effective as traditional therapy and if it can make quality care more accessible in community settings. Robots were introduced in rehabilitation in the 90s to reduce the physical effort of therapists.

Who is the study for?

This trial is for stroke survivors aged 55 or older, who are more than 3 months post-stroke with hemiplegia. Participants must be able to understand and speak, have mild to moderate arm muscle strength and motor control, and pain levels below severe on the NIH scale. Those with cerebellum lesions from their stroke or severe cognitive issues cannot join.

What is being tested?

The study compares standard care against a combination of standard care plus robot-assisted therapy using the Rehab CARES system. This phase 2 trial involves community-based patients performing clinical assessments before and after each treatment approach.

What are the potential side effects?

While specific side effects aren't detailed here, robot-assisted therapy may include discomfort or fatigue during exercises, skin irritation from equipment use, and potential frustration if progress is slower than expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a stroke.

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I can move my arms against gravity.

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I have weakness on one side of my body due to a stroke.

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My arm and hand movement is limited but not completely lost.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe problems with my memory or thinking.

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I have no brain damage from a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hand

Change in Motor Control

+4 more

Secondary study objectives

Range of Motion, Articular

Change in Cognition

Executive Function

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Robot-Assisted Therapy with Rehab CARES systemExperimental Treatment1 Intervention

60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play. Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2)

Group II: Standard of CarePlacebo Group1 Intervention

60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke, particularly in motor rehabilitation, include physical therapy, occupational therapy, and advanced methods like robot-assisted therapy. These treatments aim to enhance neuroplasticity, the brain's ability to reorganize and form new neural connections. Physical and occupational therapies involve repetitive, task-specific exercises that help retrain the brain and improve motor function. Robot-assisted therapy, such as the Rehab CARES system with force-feedback robots, provides precise, consistent, and intensive training. This technology aids in motor recovery by offering real-time feedback and adaptive resistance, which can accelerate the rehabilitation process. These mechanisms are crucial for stroke patients as they directly contribute to regaining independence and improving quality of life.