Amputation Clinical Trial
Official title:
Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain
Verified date | June 2024 |
Source | Shirley Ryan AbilityLab |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Shirley Ryan AbilityLab | Coapt, LLC |
United States,
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 |
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 |