Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

University of Pennsylvania

Status: Active, not recruiting

Conditions: Stroke; HIV/AIDS

Treatments: Other: Robot Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04488250

826195

Details and patient eligibility

About

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.

Full description

We will test the feasibility of affordable robot therapy in three Aims. In Aim 1, we will optimize for the Botswana context, an affordable technology-based robot system with four exercise stations. We will optimize a prototype of our provisionally patented robot gym system, REHAB CARES, for therapy. Optimization will include increasing cost-effectiveness, utilizing more local resources and manufacturing, and using mobile health android platforms for games and data acquisition. In Aim 2, the efficiency of the newly modified robot system compared to standard of care will be assessed using 30 patients who have experienced a stroke, with or without HIV, will be recruited from those who are being treated by Princess Marina Hospital (PMH) and living in the surrounding community. They will receive therapy using the robot gym system and receive standard of care. We will assess functional outcomes including motor impairment, function, and quality of life. The study outcomes would then inform rehabilitation practices for PLHIV with stroke, with or without HIV, and suggest that affordable technology-mediated rehabilitation can reduce their motor dysfunction and resulting long-term disability.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Low-to-mid functioning HIV/AIDS patients

Other group

Description:

Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity.

Treatment:

Other: Robot Therapy

Stroke survivors

Other group

Description:

Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.

Treatment:

Other: Robot Therapy