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Not enough patients (difficulty in recruiting according to the inclusion criteria)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjustable socket | Experimental | First week of the study is with adjustable socket |
|
| Classical socket | Experimental | First week of the study is with classical socket |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socket without Revofit system | Other | All the tests are evaluate during one week with the classical type of fittings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain change assessment | Assess the impact of the Revofitâ„¢ 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mickaël Dinomais | MD University hospital Angers | Principal Investigator |
| Yoann RONZI | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIMONAIS | Angers | 49100 | France |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Single Case Experimental Design : multiple N of 1 trial
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| Socket with Revofit system | Other | All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system) |
|
| 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 |