Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Short-form McGill Pain Questionnaire
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.
We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.
Detailed Description
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence. Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires. VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy. Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.
Investigators
Levi Hargrove
Scientific Chair, Center for Bionic Medicine
Shirley Ryan AbilityLab
Eligibility Criteria
Inclusion Criteria
- •Adults over the age of 18 years old
- •Amputation of the upper or lower limb, including amputation of multiple limbs
- •English Speaking
- •Chronic phantom limb pain (at least 6-months duration)
- •Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
- •Average frequency of phantom limb pain episode of at least twice per month.
- •Residual limb pain of less than 5 on the Numerical Pain Rating Scale
- •Pain medication use stable for \> 1 month
- •Exclusion Criteria
- •Unable to tolerate use of liner or cuff on their residual limb
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Short-form McGill Pain Questionnaire
Time Frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
The primary outcome measure in this study is change in the pain rating index (PRI) between the baseline score and at the post-treatment assessment at the end of the 8-week intervention. The PRI is computed as the sum of the scores for all descriptors of the Short Form of the McGill Pain Questionnaire (SF-MPQ).
Secondary Outcomes
- Visual Analogue Scale (VAS)(Baseline score and at the post-treatment assessment at the end of the 8-week intervention)
- Patient-Reported Outcomes Measurement Information Systems (PROMIS)(Baseline score and at the post-treatment assessment at the end of the 8-week intervention)
- Numerical Pain Rating Scale (NPRS)(Baseline score and at the post-treatment assessment at the end of the 8-week intervention)