Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

University Hospital, Angers1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amputation Adult Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 \[VAS : 0 to 10 which constitues the worst outcome\].

Time frame: four weeks

Secondary Outcomes

Everyday comfort

Quality of life assessed by daily number of adaptation of the prosthesis

Time frame: four weeks

Functional effects in twin task

A walking analysis by GAITrite once a week

Time frame: Once a week during four weeks

Functional effects in simple task

A walking analysis by a six-minute walking distance test once a week

Time frame: 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

Time frame: Once a week during four weeks

Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes