VR to Evaluate Phantom Limb Pain

NCT05915065 | Active Not Recruiting DMC

• 1 other identifier: STU00213205
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain; Phantom Pain; Phantom Sensation; Phantom Limb Syndrome With Pain; Phantom Pain Following Amputation of Lower Limb; Phantom Pain Following Amputation of Upper Limb; Amputation; Upper Limb Amputation at the Hand; Upper Limb Amputation at the Wrist; Upper Limb Amputation Below Elbow (Injury); Upper Limb Amputation Above Elbow (Injury); Lower Limb Amputation Knee; Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation at Ankle (Injury)

Keywords

Virtual Reality; Limb Loss; Amputation; Phantom Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Visual Analogue Scale (VAS)

  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

• Patient-Reported Outcomes Measurement Information Systems (PROMIS)

  Baseline score and at the post-treatment assessment at the end of the 8-week intervention

Study Arms (1)

Phantom Limb Pain Management System during at-home use.

OTHER

Participants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom * Educational documents provided on pain and phantom limb pain. * Participants are measured for an electrode cuff either in person or virtually * Complete several questionnaires. * Provided training on the Phantom Limb Pain Program with use of the electrode cuff and muscular contractions of their limb * Participate in a 8 week home trial (1.5 hours per week of use, 20-40 minutes, 4-5x each week) * Once home trial is complete - participants will be asked to participate in a phone or Zoom call at weeks 16,24 and 32 to repeat questionnaires.

Device: Coapt Phantom Limb Pain Management System

Interventions

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.

Phantom Limb Pain Management System during at-home use.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Unable to tolerate use of liner or cuff on their residual limb
• Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
• Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
• Non-English speaking

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Coapt, LLC: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Phantom Limb; Wounds and Injuries

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Levi Hargrove, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair, Center for Bionic Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: October 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

US (1)