Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- University Hospital, Angers
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Pain change assessment
- Status
- Terminated
- Last Updated
- 3 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Pain change assessment
Time Frame: four weeks
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 \[VAS : 0 to 10 which constitues the worst outcome\].
Secondary Outcomes
- Functional effects in twin task(Once a week during four weeks)
- Functional effects in simple task(Once a week during four weeks)
- Everyday comfort(four weeks)
- Patient satisfaction with assistive technology(Once a week during four weeks)