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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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
Clinique de Provence-Bourbonne
Aubagne, France
La Tour de Gassie
Bruges, France
Chu Clermont Ferrand
Clermont-Ferrand, France
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 \[Scale : On a 0 - 10 scale : 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit\]
Time frame: 50 days
Change in daily wearing time of the prosthesis
Declarative, in hours
Time frame: Every day during 50 days
Change in the daily number of steps
Measured with a pedometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 50 days
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