Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
United States, Botswana30 participantsStarted 2020-10-01
Plain-language summary
Today, nearly 37 million people are living with HIV (PLHIV) worldwide and 30 to 40% of them will have neurologic complications leading to disability. Our long-term working hypothesis is that an effective solution for increasing rehabilitation access in Botswana and improving functional outcomes of PLHIV having experienced a stroke with or without HIV uses an affordable robot and mobile health technologies to create a cost-effective intervention strategy. For this project, we test the feasibility of affordable robot therapy.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of Stroke (at least 3 months post incident) with or without HIV, age over 18;
* medically stable (Able to tolerate therapy and given the determination as able to go through protocol by physician);
* have neurological function between 5 and 24 as defined by the NIH Stroke Scale (NIHSS);
* have no less than moderate cognitive function as defined by the International HIV-Dementia Scale
* Able to give consent.
Exclusion Criteria:
* unable to give consent;
* severely depressed (Becks Depression Inventory-Fast Screener);
* experiencing excessive pain (Visual Analog Scale (VAS) score greater than 4);
* have severe spasticity ( than 3) in muscle tone in elbow/shoulder/wrist hip/knee/ankle using the Ashworth Scale;
* have total paralysis or muscular contractures of upper or lower extremity;
* have a history of psychiatric disorder or cardiac problems;
* have a history of prior brain injury including lesions to the cerebella or brain stem;
* have open lesions on the upper or lower limbs;
* It is up to the physician to decide if a subject should be excluded due to severe drug and/or alcohol abuse or taking of medication that would impair cognitive ability.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified IBM Usability Satisfaction Questionnaire
Timeframe: At 8 Weeks
2
Change in Baseline assessment of motor impairment
Timeframe: At week 8
3
Rehabilitation Capacity Questionnaire
Timeframe: At 0 week
4
Change from baseline assessment of Timed up and go
Timeframe: at 8 weeks
5
Change from baseline assessment of 10 Meter Walk Test
Timeframe: at 8 weeks
6
Change from baseline assessment of # of blocks that can be grasped and moved
Timeframe: at 8 weeks
7
Change from baseline assessment of fine motor grasp