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Robot Therapy
Robot Therapy for Stroke
N/A
Waitlist Available
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
Be older than 18 years old
Must not have
Unable to give consent
Total paralysis or muscular contractures of upper or lower extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the feasibility of using an affordable robot for rehabilitation therapy for people with HIV who have experienced a stroke.
Who is the study for?
This trial is for adults over 18 in Botswana who've had a stroke and are living with or without HIV. They should have moderate neurological function and cognitive ability, be medically stable to handle therapy, and able to consent. People with severe drug/alcohol abuse, depression, excessive pain, extreme spasticity or paralysis, psychiatric or cardiac issues, prior brain injury or open lesions can't join.
What is being tested?
The study is exploring the use of affordable robot-assisted rehabilitation combined with mobile health technologies for people in Botswana who have suffered a stroke associated with HIV. It aims to test if this approach is feasible and effective in improving their functional outcomes.
What are the potential side effects?
Since this trial involves physical rehabilitation using robots rather than medication, side effects may include muscle soreness or fatigue from therapy sessions. However specific side effects will depend on individual conditions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and give consent for treatment.
Select...
I have total paralysis or cannot move my arms or legs due to stiffness.
Select...
My muscle stiffness is severe in certain areas.
Select...
I have had a brain injury or damage to my cerebellum or brain stem.
Select...
My pain level is more than 4 on a scale of 0 to 10.
Select...
I have open wounds on my arms or legs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline assessment of # of blocks that can be grasped and moved
Change from baseline assessment of 10 Meter Walk Test
Change from baseline assessment of Timed up and go
+5 moreSide effects data
From 2015 Phase 1 & 2 trial • 59 Patients • NCT012530189%
Hospitalization to r/o new CVA
9%
Fall at home with resulting fx to study arm
5%
Seizure
5%
Atrial Fib
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transition to Task Training
Robot Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stroke survivorsExperimental Treatment1 Intervention
Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.
Group II: Low-to-mid functioning HIV/AIDS patientsExperimental Treatment1 Intervention
Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,073 Previous Clinical Trials
42,714,328 Total Patients Enrolled
31 Trials studying Stroke
4,733 Patients Enrolled for Stroke
Michelle J Johnson, PhDPrincipal InvestigatorUniversity of Pennsylvania
11 Previous Clinical Trials
2,037 Total Patients Enrolled
9 Trials studying Stroke
284 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.You have severe depression according to a specific test called Becks Depression Inventory-Fast Screener.I had a stroke at least 3 months ago and am over 18.I have total paralysis or cannot move my arms or legs due to stiffness.My muscle stiffness is severe in certain areas.I have had a brain injury or damage to my cerebellum or brain stem.My pain level is more than 4 on a scale of 0 to 10.You need to have pretty good thinking and memory skills according to a specific test.I have open wounds on my arms or legs.You have a history of mental health issues or heart problems.Your neurological function, as measured by the NIH Stroke Scale, falls between 5 and 24.
Research Study Groups:
This trial has the following groups:- Group 1: Stroke survivors
- Group 2: Low-to-mid functioning HIV/AIDS patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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