Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clin-Experts | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-FLEX PIVOT | Experimental | The patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days |
|
| Class III ESAR foot | Active Comparator | The patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-FLEX PIVOT Foot evaluation | Device | The subject will wear the PRO-FLEX PIVOT foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test |
| Measure | Description | Time Frame |
|---|---|---|
| Change of mobility of the patient | Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-Mâ„¢) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in comfort experienced during the wearing of the foot | Evaluate the impact of the foot on the comfort experienced by the patient with visual analog scale (VAS) from 0 (= not at all comfortable) to 5 (=Very comfortable) | 28 days |
| Change in quality of life |
Not provided
Inclusion Criteria:
Adult patient (over 18 years of age)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Noël MARTINET, PhD | IRR - Établissement de Nancy - Louis-Pierquin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiples locations | Multiple Locations | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Class III ESAR Foot evaluation | Device | The subject will wear his usual Class III ESAR Foot foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test |
|
Evaluate the impact of the foot on the quality of life assessed by the Orthotics Prosthetics Users Survey (OPUS) patient Self report questionnaire. The higher the score [0-92], the better the perception of quality of life. |
| 28 days |
| Change in satisfaction of the patient | Assess the change in patient satisfaction with Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); Higher scores indicate greater satisfaction. | 28 days |
| Occurence of falls | 28 days |
| Number of patients with technical incidents | 28 days |