NCT05915065

VR to Evaluate Phantom Limb Pain

Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-06-22
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States