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Active, Not Recruiting

NCT Number: NCT04488250

Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Nervous System Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stroke Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Botswana, Gaborone, Botswana

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot Therapy

Other

Robot Therapy

Primary outcomes

  1. Modified IBM Usability Satisfaction Questionnaire

    Time frame: At 8 Weeks

    Assess usability of the robot system with patients and therapists

  2. Change in Baseline assessment of motor impairment

    Time frame: At week 8

    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

  3. Rehabilitation Capacity Questionnaire

    Time frame: At 0 week

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

  4. Change from baseline assessment of Timed up and go

    Time frame: at 8 weeks

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

  5. Change from baseline assessment of 10 Meter Walk Test

    Time frame: at 8 weeks

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

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

    Time frame: at 8 weeks

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

  7. Change from baseline assessment of fine motor grasp

    Time frame: at 8 weeks

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

  8. Change from baseline assessment of stroke impact scale

    Time frame: at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2020
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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