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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Clinical and instrumented measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT01848964

2013-A00219-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Evaluation

Experimental group

Description:

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.

Treatment:

Device: Clinical and instrumented measurements