Clinical trial NCT01848964: Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee
Official title: Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lower Limb Amputation Above Knee (Injury)
Keywords: amputation
prosthesis
stump
socket
pressure
gait
posture
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
First posted: 2013-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees.

The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.

Detailed description: Forty amputee patients will be evaluated for satisfaction with the prosthesis, pressure repartition pattern and functional capabilities.

Pressure at the stump-socket interface will be recorded using a set of 14 single cells sensors placed in predefined positions onto the stump. Pattern of pressure will be measured in four tasks: sitting posture, standing posture, gait initiation, and gait at preferred velocity.

Reproducibility of the pressure repartition pattern will be analyzed by repeating gait and standing posture task in the first 15 patients included.

In patients whom prosthesis has been modified on the basis on the first pressure measurement (pressure peak and bad functional capacities), a new pressure measurement will be repeated 2-8 weeks apart.

Postural and gait abilities will be also assessed in 40 age/gender matched non-amputated subjects to serve as control data.

Eligibility criteria: 1. Amputee patients:

   Inclusion Criteria:
   * unilateral transfemoral amputation
   * use of a prosthesis with a "contact" socket

   Exclusion Criteria:
   * neurological or muscular disorder likely to impair walking capabilities
   * Mini Mental State Examination below 24/30
2. Healthy subjects :

Exclusion Criteria:

* neurological or muscular disorder likely to impair walking capabilities
* Mini Mental State Examination below 24/30

Primary outcomes:
measure: Two minute Walking Test
timeFrame: At inclusion (baseline) for all patients
Secondary outcomes:
measure: Variation coefficient of maximal pressures during gait
timeFrame: At inclusion (Baseline) for all patients
measure: Change in two minutes walk tests between Baseline and 5 Weeks
timeFrame: Five weeks (W5) in average after inclusion in patients in whom the prosthesis will be modified
measure: Change in the variation coefficients of maximal pressures between Baseline and 5 Weeks
timeFrame: 5 Weeks in average (2 and 8 weeks) after the inclusion in patients in whom the prosthesis will be modified
measure: Gait spatial and temporal parameters
timeFrame: At inclusion for all patients
measure: Variation coefficient of maximal pressure during standing posture
timeFrame: At inclusion for all patients
measure: Reproducibility of the Variation Coefficients of maximal pressures
timeFrame: At baseline
Other outcomes:
measure: Occurrence of pain, dyscomfort, or skin wound due to the measurement system
timeFrame: at baseline
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Dominic Pérennou, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: