VR to Evaluate Phantom Limb Pain

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT05915065
Study type	Interventional
Source	Shirley Ryan AbilityLab
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 1, 2020
Completion date	September 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.