Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System

Study Overview
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Brief Summary
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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.

Official Title
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Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial

Conditions
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Amputation

Intervention / Treatment
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* Device: Vacuum suspension system active or inactive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years of age. Unilateral transtibial amputation for more than 6 months. Equipped for more than 3 months with a Seal-in™ liner without the vacuum suspension system. Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspension system Patient meeting the criteria of ICF(International Classification of Functioning, Disability and Health) classification d4602 and/or d4608 Presenting some discomfort in the socket evaluated by a SCS ≤ 7/10 Absence of severe comorbidity Patient with a smartphone and a functional 4G connection Exclusion Criteria: Cognitive impairment that does not allow instructions to be followed Have already been equipped with the evaluated vacuum suspension system Pregnant women Patient subject to a legal protection measure Patient not affiliated with social security

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Device active or inactive<br>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 | Device: Vacuum suspension system active or inactive<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Elevated vacuum, Prosthetic suspension system, Vacuum-assisted suspension, N-of-1 Trial