Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adjustable socket First week of the study is with adjustable socket |
Other: Socket without Revofit system
All the tests are evaluate during one week with the classical type of fittings
Other: Socket with Revofit system
All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)
|
| Experimental: Classical socket First week of the study is with classical socket |
Other: Socket without Revofit system
All the tests are evaluate during one week with the classical type of fittings
Other: Socket with Revofit system
All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)
|
Outcome Measures
Primary Outcome Measures
- Pain change assessment [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 Outcome Measures
- Everyday comfort [four weeks]
Quality of life assessed by daily number of adaptation of the prosthesis
- Functional effects in twin task [Once a week during four weeks]
A walking analysis by GAITrite once a week
- Functional effects in simple task [Once a week during four weeks]
A walking analysis by a six-minute walking distance test once a week
- Patient satisfaction with assistive technology [Once a week during four weeks]
Assessment of patient satisfaction by using Quebec User Evaluation of Satisfaction with assistive Technology [QUEST] survey
Eligibility Criteria
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:
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Patient with peripheral neuropathies contraindicating the use of Revofit system
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Pregnant woman, nursing mother or parturiant
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Patient in detention by judicial or administrative decision
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DIMONAIS | Angers | France | 49100 |
Sponsors and Collaborators
- University Hospital, Angers
Investigators
- Principal Investigator: Mickaël Dinomais, MD University hospital Angers
- Principal Investigator: Yoann RONZI, MD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 49RC19_0129