Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital, Grenoble
Sponsor:
Collaborator:
TIMC-IMAG
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01848964
First received: April 19, 2013
Last updated: May 5, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Lower Limb Amputation Above Knee (Injury)
Device: Clinical and instrumented measurements
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Two minute Walking Test [ Time Frame: At inclusion (baseline) for all patients ] [ Designated as safety issue: No ]
    Maximal distance(m)walked during 2 minutes (one trial)


Secondary Outcome Measures:
  • Variation coefficient of maximal pressures during gait [ Time Frame: At inclusion (Baseline) for all patients ] [ Designated as safety issue: No ]

    Calculated on the basis of 10 walking trials of 10 meters. The maximal pressure will be measured at each step for each sensor. The mean maximal pressure is calculated for each of the 14 sensors. The variation coefficient is calculated between these 14 values (variation coefficient = standard deviation/mean)

    A low variation coefficient of pressure is supposed to represent an homogeneous repartition of the pressure in the prosthesis.


  • Change in two minutes walk tests between Baseline and 5 Weeks [ Time Frame: Five weeks (W5) in average after inclusion in patients in whom the prosthesis will be modified ] [ Designated as safety issue: No ]

    If a modification of the prosthesis is required and performed on the basis of the first assessment (at inclusion), a new assessment with the modified prosthesis is performed 5 weeks later (from 2 to 8 weeks).

    Change in walking capabilities is assessed by calculating the difference between results of the two minute walk test at inclusion and at 5 weeks.


  • Change in the variation coefficients of maximal pressures between Baseline and 5 Weeks [ Time Frame: 5 Weeks in average (2 and 8 weeks) after the inclusion in patients in whom the prosthesis will be modified ] [ Designated as safety issue: No ]

    If a modification of the prosthesis is required and performed on the basis of the first assessment (at inclusion), a new assessment with the modified prosthesis is performed 5 weeks later (from 2 to 8 weeks).

    Change of repartition pattern will be assessed by calculating the difference between the variation coefficient before and after the prosthesis modification.


  • Gait spatial and temporal parameters [ Time Frame: At inclusion for all patients ] [ Designated as safety issue: No ]
    Calculated based on 10 walking trial of 10 meters. Speed, step length of the prosthetic and non-amputated leg and standing time on the prosthetic and non-amputated leg

  • Variation coefficient of maximal pressure during standing posture [ Time Frame: At inclusion for all patients ] [ Designated as safety issue: No ]
    Calculated based on 4 standing trial of 30 seconds. The calculation is the same as for gait, but the mean pressure during the postural trial will be used instead of the maximal pressure during the step.

  • Reproducibility of the Variation Coefficients of maximal pressures [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    At inclusion (baseline), the measurements of pressure repartition pattern in gait and standing posture tasks will be repeated twice, in order to test inter- and intra-evaluator reproducibility.


Other Outcome Measures:
  • Occurrence of pain, dyscomfort, or skin wound due to the measurement system [ Time Frame: at baseline ] [ Designated as safety issue: Yes ]
    By structured interview, visual analogic pain scale, and clinical examination at the end of the baseline assessment.


Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evaluation

First, the assessment will be performed to evaluate the relationship between pressure repartition pattern, clinical evaluation and motor capabilities. All the patients and volunteers will be concerned by this first part.

A second part will be conducted in 15 amputees within the 40 patients. Assessments of pressure pattern during gait and standing will be repeated two times: by the same investigator and by a different investigator, in order to test intra- and inter-evaluator reproducibility.

After the first assessment, the prosthesis may be modified in order to solve clinical problems. In that case, a new assessment will be proposed 2 to 8 weeks after in order to test the effect of the prosthesis modification on pressure pattern, gait, posture and clinical parameters.

Device: Clinical and instrumented measurements

Clinical examination will include stump pain, wound, scar and unusual shape.

Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI)

After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation.

Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors.

Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate.


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848964

Contacts
Contact: Dominic Pérennou, MD PhD 04 76 76 60 83 ext +33 DPerennou@chu-grenoble.fr
Contact: Bruno Saurel, PT 04 76 76 60 77 ext +33 BSaurel@chu-grenoble.fr

Locations
France
University Hospital Recruiting
Grenoble, France, 38000
Contact: Dominic Pérennou, MD PhD    04 76 76 60 83 ext +33    DPerennou@chu-grenoble.fr   
Contact: Bruno Saurel, PT    04 76 76 60 77 ext +33    BSaurel@chu-grenoble.fr   
Sub-Investigator: Marie-Pierre De Angelis, MD         
Sub-Investigator: Vanessa Seetha, MD         
Sub-Investigator: Bastien Moineau, PT         
Sub-Investigator: Bruno Saurel, PT         
Sub-Investigator: Vincent Nougier, Prof         
Sub-Investigator: Pierre Chabloz, orthoprosth.         
Sub-Investigator: Cécile Meynard, orthoprosth.         
Sponsors and Collaborators
University Hospital, Grenoble
TIMC-IMAG
Investigators
Principal Investigator: Dominic Pérennou, MD PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01848964     History of Changes
Other Study ID Numbers: 2013-A00219-36
Study First Received: April 19, 2013
Last Updated: May 5, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
amputation
prosthesis
stump
socket
pressure
gait
posture

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014