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VR to Evaluate Phantom Limb Pain

NCT05915065 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-14

No results posted yet for this study

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)

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Coapt, LLC

    collaborator INDUSTRY

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Levi Hargrove, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05915065 on ClinicalTrials.gov