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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; HIV/AIDS
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Johnson, PhD; Phone Number: 2158932665; Email: johnmic@pennmedicine.upenn.edu

Study Locations

• Botswana
  • Gaborone, Botswana
    • University of Botswana
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Penn Medicine Rittenhouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Robot Therapy
Other: Stroke survivors; Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.	Other: Robot Therapy; Robot Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Michelle J Johnson, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 826195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No