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Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

Primary Purpose

HIV/AIDS, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Robot Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn Medicine Rittenhouse
  • University of BotswanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low-to-mid functioning HIV/AIDS patients

Stroke survivors

Arm Description

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

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

Outcomes

Primary Outcome Measures

Modified IBM Usability Satisfaction Questionnaire
Assess usability of the robot system with patients and therapists
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
Rehabilitation Capacity Questionnaire
Survey for all therapists and rehab professionals - up to 1 hour; interview
Change from baseline assessment of Timed up and go
Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.
Change from baseline assessment of 10 Meter Walk Test
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2019
Last Updated
December 1, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04488250
Brief Title
Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
Official Title
Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-to-mid functioning HIV/AIDS patients
Arm Type
Other
Arm Description
Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity.
Arm Title
Stroke survivors
Arm Type
Other
Arm Description
Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.
Intervention Type
Other
Intervention Name(s)
Robot Therapy
Intervention Description
Robot Therapy
Primary Outcome Measure Information:
Title
Modified IBM Usability Satisfaction Questionnaire
Description
Assess usability of the robot system with patients and therapists
Time Frame
At 8 Weeks
Title
Change in Baseline assessment of motor impairment
Description
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
Title
Rehabilitation Capacity Questionnaire
Description
Survey for all therapists and rehab professionals - up to 1 hour; interview
Time Frame
At 0 week
Title
Change from baseline assessment of Timed up and go
Description
Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.
Time Frame
at 8 weeks
Title
Change from baseline assessment of 10 Meter Walk Test
Description
Measure gait distance capacity. Measured in meters. Longer distance means lower impairment.
Time Frame
at 8 weeks
Title
Change from baseline assessment of # of blocks that can be grasped and moved
Description
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
Title
Change from baseline assessment of fine motor grasp
Description
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
Title
Change from baseline assessment of stroke impact scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Johnson, PhD
Phone
2158932665
Email
johnmic@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle J Johnson, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine Rittenhouse
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Botswana
City
Gaborone
Country
Botswana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maikutlo Kebaetse, PhD
Phone
267-355-4606

12. IPD Sharing Statement

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Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

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