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

NCT01848964 | Completed Phase 1 DMC

• 1 other identifier: 2013-A00219-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

amputation; prosthesis; stump; socket; pressure; gait; posture

Outcome Measures

Primary Outcomes (1)

• Two minute Walking Test

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

  At inclusion (baseline) for all patients

Secondary Outcomes (6)

• Variation coefficient of maximal pressures during gait

  At inclusion (Baseline) for all patients

• Change in two minutes walk tests between Baseline and 5 Weeks

  Five weeks (W5) in average after inclusion in patients in whom the prosthesis will be modified

• Change in the variation coefficients of maximal pressures between Baseline and 5 Weeks

  5 Weeks in average (2 and 8 weeks) after the inclusion in patients in whom the prosthesis will be modified

• Gait spatial and temporal parameters

  At inclusion for all patients

• Variation coefficient of maximal pressure during standing posture

  At inclusion for all patients

Other Outcomes (1)

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

  at baseline

Study Arms (1)

Evaluation

EXPERIMENTAL

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

Interventions

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.

Evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral transfemoral amputation
• use of a prosthesis with a "contact" socket

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• TIMC-IMAG: collaborator

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Dominic Pérennou, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

FR (1)