Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Study Overview
=================
Brief Summary
-----------------
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.

Detailed Description
-----------------
With the  multiple N-of-1 trial  study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.

Official Title
-----------------
Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial

Conditions
-----------------
Adult Disease, Amputation

Intervention / Treatment
-----------------
* Other: Socket without Revofit system
* Other: Socket with Revofit system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years old and above Above knee or below knee amputation (irrespective of etiology and time from amputation) Residual limb pain Prosthetic with classic fitting Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting …) Recipients or registered with a social security scheme Informed consent form signed beforehand Exclusion Criteria: Patient with peripheral neuropathies contraindicating the use of Revofit system Pregnant woman, nursing mother or parturiant Patient in detention by judicial or administrative decision Patient undergoing psychiatric compulsory care Patient in a health or social institution for purposes other than research Legally protected person Patient unable to express their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single Case Experimental Design : multiple N of 1 trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjustable socket<br>First week of the study is with adjustable socket | Other: Socket without Revofit system<br>* All the tests are evaluate during one week with the classical type of fittings<br>Other: Socket with Revofit system<br>* All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)<br>|
| Experimental: Classical socket<br>First week of the study is with classical socket | Other: Socket without Revofit system<br>* All the tests are evaluate during one week with the classical type of fittings<br>Other: Socket with Revofit system<br>* All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change assessment | Assess the impact of the Revofit™ system adjusted-fitting on residual limb pain compared to a classic fitting with a daily Visual Analog Scale evaluation [VAS : 0 to 10 which constitues the worst outcome]. | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Everyday comfort | Quality of life assessed by daily number of adaptation of the prosthesis | four weeks | 
| Functional effects in twin task | A walking analysis by GAITrite once a week | Once a week during four weeks | 
| Functional effects in simple task | A walking analysis by a six-minute walking distance test once a week | Once a week during four weeks | 
| Patient satisfaction with assistive technology | Assessment of patient satisfaction by using Quebec User Evaluation of Satisfaction with assistive Technology [QUEST] survey | Once a week during four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
residual limbs, pain, adjustable socket