Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
- Conditions
- Amputation
- Interventions
- Device: Vacuum suspension system active or inactive
- Registration Number
- NCT04804150
- Lead Sponsor
- Össur Ehf
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medical Device active or inactive Vacuum suspension system active or inactive 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
- Primary Outcome Measures
Name Time Method Confort change assessment 50 days 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 \[Scale : On a 0 - 10 scale : 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit\]
- Secondary Outcome Measures
Name Time Method Assessment of the stump volume variation Every day during 50 days 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 lotChange in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology Up to 50 days 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
Change in daily wearing time of the prosthesis Every day during 50 days Declarative, in hours
Change in 6 Minute Walk Test (6MWT) Up to 50 days 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
Change in the daily number of steps Every day during 50 days Measured with a pedometer
Change L-Test of Functional Mobility Up to 50 days The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns
Change in confidence in maintaining balance while doing daily activities Up to 50 days Measured by the simplified Activities-specific Balance Confidence Scale (ABC-S)
Assessment of limb-prosthesis coaptation Every day during 50 days 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
Trial Locations
- Locations (3)
Clinique de Provence-Bourbonne
🇫🇷Aubagne, France
La Tour de Gassie
🇫🇷Bruges, France
Chu Clermont Ferrand
🇫🇷Clermont-Ferrand, France