Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

NCT04488250 | Active Not Recruiting

• 1 other identifier: 826195
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV/AIDS; Stroke

Outcome Measures

Primary Outcomes (8)

• Modified IBM Usability Satisfaction Questionnaire

  Assess usability of the robot system with patients and therapists

  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

  At week 8

• Rehabilitation Capacity Questionnaire

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

  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.

  at 8 weeks

• Change from baseline assessment of 10 Meter Walk Test

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

  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.

  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.

  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.

  at 8 weeks

Study Arms (2)

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.

Other: Robot Therapy

Stroke survivors

OTHER

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

Other: Robot Therapy

Interventions

Robot Therapy OTHER

Robot Therapy

Low-to-mid functioning HIV/AIDS patients; Stroke survivors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

University of Botswana

Gaborone, Botswana

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle J Johnson, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: July 27, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1); BO (1)