HIV/AIDSNCT04488250
Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
A study testing Robot Therapy in people with HIV/AIDS and Stroke, run by University of Pennsylvania at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Robot Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
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.
- Being tested
- Robot Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot TherapyOther
Robot Therapy
| Study group | Role | What they receive |
|---|---|---|
| Low-to-mid functioning HIV/AIDS patients | Other | Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity. Receives: Other: Robot Therapy |
| Stroke survivors | Other | Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS. Receives: Other: Robot Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified IBM Usability Satisfaction Questionnaire
Assess usability of the robot system with patients and therapists
Measured: At 8 Weeks
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
Measured: At week 8
Rehabilitation Capacity Questionnaire
Survey for all therapists and rehab professionals - up to 1 hour; interview
Measured: At 0 week
Change from baseline assessment of Timed up and go
Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.
Measured: at 8 weeks
Change from baseline assessment of 10 Meter Walk Test
Measure gait distance capacity. Measured in meters. Longer distance means lower impairment.
Measured: at 8 weeks
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.
Measured: at 8 weeks
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.
Measured: at 8 weeks
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.
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Oct 2020
- Primary completion30 Jul 2026
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488250
- Sponsor's protocol ID
- 826195
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
- ClinicalTrials.gov ID
- NCT04488250
- Acronym / sponsor ID
- 826195
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-to-mid functioning HIV/AIDS patients | Other | Other: Robot TherapyLow-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity. |
| Stroke survivors | Other | Other: Robot TherapyStroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot TherapyRobot Therapy | Other | Low-to-mid functioning HIV/AIDS patients, Stroke survivors |
Primary outcome
Modified IBM Usability Satisfaction Questionnaire
Time frame: At 8 Weeks
Assess usability of the robot system with patients and therapists
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
Rehabilitation Capacity Questionnaire
Time frame: At 0 week
Survey for all therapists and rehab professionals - up to 1 hour; interview
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle J Johnson, PhD principal investigator
University of Pennsylvania
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Therapy in people with HIV/AIDS and Stroke, run by University of Pennsylvania at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified IBM Usability Satisfaction Questionnaire (time frame: At 8 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.