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| Name | Class |
|---|---|
| Clin-Experts | INDUSTRY |
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The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective, randomized, double-blind, multiple N-of-1 trial.
In order to assess the therapeutic effect of the vacuum suspension system, given the heterogeneity of the population and the small number of patients eligible for the study, the multiple N-of-1 trial seems to us to be the methodology. The principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Device active or inactive | Experimental | The medical device will be active, or inactive. Randomization will define when and how long time the medical device will plugged and active, and when and how long time the medical device will be unplugged and inactive. The patient won't know if the medical device is active or not |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum suspension system active or inactive | Device | The device will be plugged in, or won't be plugged in, depending of the randomization. The patient and the investigator will not know whether the device is plugged in or not, and if the medical device is active or not |
| Measure | Description | Time Frame |
|---|---|---|
| Confort change assessment | Assess the impact of the vacuum suspension system on the fitting's comfort compared to the vacuum suspension system inactive system with a daily evaluation on Socket Comfort Score [Scale : On a 0 - 10 scale : 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit] | 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daily wearing time of the prosthesis | Declarative, in hours | Every day during 50 days |
| Change in the daily number of steps | Measured with a pedometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| REMI KLOTZ, MD | LA TOUR DE GASSIES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Provence-Bourbonne | Aubagne | 13400 | France | |||
| La Tour de Gassie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37452356 | Derived | Klotz R, Emile G, Daviet JC, De Seze M, Godet J, Urbinelli R, Krasny-Pacini A. Daily socket comfort in transtibial amputee with a vacuum-assisted suspension system: study protocol of a randomized, multicenter, double-blind multiple N-of-1 trial. BMC Sports Sci Med Rehabil. 2023 Jul 14;15(1):85. doi: 10.1186/s13102-023-00694-4. |
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Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
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The medical device will be active (plugged) or inactive (unplugged), but the patient nor the investigator won't know if the medical device is active(plugged) or inactive (unplugged).
After one-month accommodation period, patient will be randomly distributed into active or inactive vacuum 7 to 28 days phases with at least three phase change and a maximum of 50 days. The randomization will use a phase length ABAB randomization rather than block randomization commonly used in drug trials. However, because the patient has to come to the rehabilitation center at each phase change which would not allow the patient and the assessors to be blind to the next phase content, phases of a duration >14, will be further randomized into two half-phases of the same content with a placebo visit between the two half-phases, in order to keep the blinding. All sequences containing 3 true transition of activation/inactivation of the medical device and up to 3 placebo transitions
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| Every day during 50 days |
| Assessment of the stump volume variation | The stump volume variation will be assessed by 2 questions : How many times have you removed your prosthesis during the day (not counting the evening's removal) to add compensation sheaths? " 0, 1, 2, 3, 4, >4 Did you have the fear at one (or more) moment(s) of the day, of losing your prosthesis, that it would come off by itself? " Visual Analogue Scale (VAS) of 0: no not at all at 10 = yes a lot | Every day during 50 days |
| Assessment of limb-prosthesis coaptation | The limp-prosthesis coaptation will be assessed by 2 questions : "Do you feel that you have mastered your prosthesis, that it is one with you?" VAS from 0 = not at all to 10 =perfectly "Do you feel a piston movement of your prosthesis when walking (sensation of vertical movement of the prosthesis in relation to the stump when walking)?" VAS from 0 = not at all to 10 = yes a lot | Every day during 50 days |
| Change L-Test of Functional Mobility | The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns | Up to 50 days |
| Change in 6 Minute Walk Test (6MWT) | The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed | Up to 50 days |
| Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology | Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction | Up to 50 days |
| Change in confidence in maintaining balance while doing daily activities | Measured by the simplified Activities-specific Balance Confidence Scale (ABC-S) | Up to 50 days |
| Bruges |
| 33523 |
| France |
| Chu Clermont Ferrand | Clermont-Ferrand | 63000 | France |