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NCT Number: NCT01848964

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

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.

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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • Healthy subjects :

Exclusion criteria

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

Treatment and study plan

Clinical and instrumented measurements

Device

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.

Primary outcomes

  1. Two minute Walking Test

    Time frame: At inclusion (baseline) for all patients

    Maximal distance(m)walked during 2 minutes (one trial)

Secondary outcomes

  1. Variation coefficient of maximal pressures during gait

    Time frame: At inclusion (Baseline) for all patients

    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.

  2. 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

    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.

  3. 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

    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.

  4. Gait spatial and temporal parameters

    Time frame: At inclusion for all patients

    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

  5. Variation coefficient of maximal pressure during standing posture

    Time frame: At inclusion for all patients

    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.

  6. Reproducibility of the Variation Coefficients of maximal pressures

    Time frame: At baseline

    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 outcomes

  1. Occurrence of pain, dyscomfort, or skin wound due to the measurement system

    Time frame: at baseline

    By structured interview, visual analogic pain scale, and clinical examination at the end of the baseline assessment.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • TIMC-IMAG

Registry information

Official study title

Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 8, 2013
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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