VR to Evaluate Phantom Limb Pain

NCT ID: NCT05915065

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-09-30

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.

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Phantom Limb Pain Management System during at-home use.

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.

Group Type: OTHER

Coapt Phantom Limb Pain Management System

Intervention Type: 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.

Interventions

Coapt Phantom Limb Pain Management System

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.

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coapt, LLC

INDUSTRY

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Levi Hargrove

Scientific Chair, Center for Bionic Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Levi Hargrove, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00213205

Identifier Type: -

Identifier Source: org_study_id