Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05915065
Other study ID # STU00213205
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2025

Study information

Verified date June 2024
Source Shirley Ryan AbilityLab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date September 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Shirley Ryan AbilityLab Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Shirley Ryan AbilityLab Coapt, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Visual Analogue Scale (VAS) The pain VAS is a unidimensional measure of pain intensity, used to record a persons pain progression, or compare pain severity between paints with similar conditions. Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary Numerical Pain Rating Scale (NPRS) The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary Patient-Reported Outcomes Measurement Information Systems (PROMIS) ROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults. PROMIS measures can be used with the general population and with individuals living with chronic conditions. Baseline score and at the post-treatment assessment at the end of the 8-week intervention
See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Recruiting NCT04725006 - Sensory Responses to Dorsal Root Stimulation N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A