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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
>3 months post-stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Awards & highlights

Study Summary

This trial will test whether using robots to help deliver therapy to stroke patients in a community setting can improve outcomes.

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.Check my eligibility
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.See study design
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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It has been over 3 months since my stroke.
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I am 55 years old or older.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hand
Hand
Change in Motor Control
+4 more
Secondary outcome measures
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).

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,879,207 Total Patients Enrolled
29 Trials studying Stroke
2,165 Patients Enrolled for Stroke
enAble Games LLCUNKNOWN
Recupero Robotics LLCUNKNOWN

Media Library

Robot-Assisted Therapy with Rehab CARES system Clinical Trial Eligibility Overview. Trial Name: NCT05542121 — N/A
Stroke Research Study Groups: Standard of Care, Robot-Assisted Therapy with Rehab CARES system
Stroke Clinical Trial 2023: Robot-Assisted Therapy with Rehab CARES system Highlights & Side Effects. Trial Name: NCT05542121 — N/A
Robot-Assisted Therapy with Rehab CARES system 2023 Treatment Timeline for Medical Study. Trial Name: NCT05542121 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this research?

"Affirmative. Clinicaltrials.gov's records demonstrate that this research is still enrolling patients, beginning on June 1st 2022 and recently updated September 29th 2022. 36 individuals need to be selected from 2 medical centres."

Answered by AI

Are there opportunities for trial participants at this juncture?

"Confirmation of this medical trial's status is available on clinicaltrials.gov, which indicates that it is currently recruiting participants. The initial date of posting was June 1st 2022 and the last update took place on September 29th 2022."

Answered by AI

What are the main aims of this trial?

"This medical trial has two main objectives: to measure Upper Extremity Function over 12 sessions and 4 weeks of follow-up, as well as evaluate Exertion via the Borg Exertive Scale (0 - 10 with 0 being low exertion), Active Joint Range of Motion (ROM) through upper limb joint testing reported in degrees, and Usability by System Usability Scale (100 point scale with 68 being ideal). Additionally, patients will report any pain experienced throughout 60 minutes."

Answered by AI

Who else is applying?

What site did they apply to?
Penn Medicine Rittenhouse
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby May 2024