Clinical trial NCT04488250: Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
Official title: Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Low-to-mid functioning HIV/AIDS patients with stroke co-morbidity. Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified IBM Usability Satisfaction Questionnaire
timeFrame: At 8 Weeks
measure: Change in Baseline assessment of motor impairment
timeFrame: At week 8
measure: Rehabilitation Capacity Questionnaire
timeFrame: At 0 week
measure: Change from baseline assessment of Timed up and go
timeFrame: at 8 weeks
measure: Change from baseline assessment of 10 Meter Walk Test
timeFrame: at 8 weeks
measure: Change from baseline assessment of # of blocks that can be grasped and moved
timeFrame: at 8 weeks
measure: Change from baseline assessment of fine motor grasp
timeFrame: at 8 weeks
measure: Change from baseline assessment of stroke impact scale
timeFrame: at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
city: Gaborone
country: Botswana
facility: University of Botswana
Study officials:
affiliation: University of Pennsylvania
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: