ClinicalTrials.gg
Active, not recruitingNCT04488250Updated Aug 10, 2026

Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

An interventional study of Robot Therapy in HIV/AIDS and Stroke, sponsored by University of Pennsylvania. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's planned enrollment of 30 is below the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of Stroke (at least 3 months post incident) with or without , 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Low-to-mid functioning HIV/AIDS patients

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

    Other: Robot Therapy

  • Other
    Stroke survivors

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

    Other: Robot Therapy

Interventions

  • OtherRobot Therapy

    Robot Therapy

06

What researchers measure

Primary outcomes

  1. Modified IBM Usability Satisfaction Questionnaire

    Assess usability of the robot system with patients and therapists

    Time frame: At 8 Weeks

  2. Change in Baseline assessment of motor impairment

    The Fugl-Meyer measure of motor impairment in the upper limb. Max is 66. Min 0; higher is better. up to 30 minutes to complete

    Time frame: At week 8

  3. Rehabilitation Capacity Questionnaire

    Survey for all therapists and rehab professionals - up to 1 hour; interview

    Time frame: At 0 week

  4. Change from baseline assessment of Timed up and go

    Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.

    Time frame: at 8 weeks

  5. Change from baseline assessment of 10 Meter Walk Test

    Measure gait distance capacity. Measured in meters. Longer distance means lower impairment.

    Time frame: at 8 weeks

  6. Change from baseline assessment of # of blocks that can be grasped and moved

    Box and Block Test is a reach and grasp test - gross motor function. Measured in # of blocks. Higher number of blocks means lower impairment.

    Time frame: at 8 weeks

  7. Change from baseline assessment of fine motor grasp

    Grooved Peg-Board Test is measure of fine motor grasp. Measured in times and number of pins placed. More pins placed means lower impairment.

    Time frame: at 8 weeks

  8. Change from baseline assessment of stroke impact scale

    quality of life questionnaire; self-reported. The Stroke Impact Scale (SIS) assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function. Higher scores means less impaired. Lower score is more impaired.

    Time frame: at 8 weeks

07

Study locations

2 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04488250
Responsible party
Sponsor
First posted
Jul 27, 2020
Start date
Oct 1, 2020
Primary completion
Jul 30, 2026
Completion
Jul 30, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Michelle J Johnson, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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