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| Name | Class |
|---|---|
| Coapt, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phantom Limb Pain Management System during at-home use. | Other | Participants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coapt Phantom Limb Pain Management System | Device | The PLP-MS consists of (1) an expandable arm/leg cuff with electrode sensors to collect EMG signals from residual limb muscles, (2) an integrated hardware module (the Coapt Complete Control Gen2.5 system) that translates users' EMG signals into game commands, (3) game software for mobile applications, and (4) a secure, HIPAA-compliant cloud-based data storage system for storing and retrieving user data remotely. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-form McGill Pain Questionnaire | 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). | Baseline score and at the post-treatment assessment at the end of the 8-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | The pain VAS is a unidimensional measure of pain intensity, used to record a persons pain progression, or compare pain severity between paints with similar conditions. | Baseline score and at the post-treatment assessment at the end of the 8-week intervention |
| Numerical Pain Rating Scale (NPRS) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Levi Hargrove, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
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This study will enroll one, non-random group of amputees to participate in 2-4 in person or virtual research visits, participate in a home trial and complete questionnaires pre home trial, at various points during the home trial and upon conclusion of the home trial.
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The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. |
| Baseline score and at the post-treatment assessment at the end of the 8-week intervention |
| Patient-Reported Outcomes Measurement Information Systems (PROMIS) | ROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults. PROMIS measures can be used with the general population and with individuals living with chronic conditions. | Baseline score and at the post-treatment assessment at the end of the 8-week intervention |
| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
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