Amputation Clinical Trial
Official title:
Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
Verified date | July 2022 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 10, 2021 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | DIMONAIS | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Everyday comfort | Quality of life assessed by daily number of adaptation of the prosthesis | four weeks | |
Secondary | Functional effects in twin task | A walking analysis by GAITrite once a week | Once a week during four weeks | |
Secondary | Functional effects in simple task | A walking analysis by a six-minute walking distance test once a week | Once a week during four weeks | |
Secondary | 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 |
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