Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Confort change assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Confort change assessment
Time Frame: 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 Outcomes
- Assessment of the stump volume variation(Every day during 50 days)
- Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology(Up to 50 days)
- Change in daily wearing time of the prosthesis(Every day during 50 days)
- Change in 6 Minute Walk Test (6MWT)(Up to 50 days)
- Change in the daily number of steps(Every day during 50 days)
- Change L-Test of Functional Mobility(Up to 50 days)
- Change in confidence in maintaining balance while doing daily activities(Up to 50 days)
- Assessment of limb-prosthesis coaptation(Every day during 50 days)