Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees

January 21, 2016 updated by: Dr. Itzhak Siev-Ner, Sheba Medical Center

Evaluation of the Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees

Background:

Trauma is the second most common factor for transtibial amputations, just after vascular background. Traumatic amputees generally function better than amputees due to vascular background. The type of prosthetic foot fitted to the patient depends on his mobility and functional level, and significantly influences his stability and gait symmetry. A prosthetic foot with a hydraulic ankle provides significant advantages for high level functioning amputees: decrease of loads in the residuum, improvement in symmetry and generally gait pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded to include computerized control over the ankle movement, using input from an array of sensors inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern that is more similar to healthy people. However, hydraulic feet with and without computer control have not been compared. Furthermore, the effects of a computerized foot on various important factors have not been investigated yet, e.g. loads in the residuum, the movement of the center of pressure and the patient's satisfaction.

Research objectives:

To compare between hydraulic prosthetic feet, with and without computerized control. The comparison will be made while walking on flat or inclined surfaces (positive or negative inclination). Differences in gait parameters, loads inside the residuum, center of mass movement and patient's satisfaction will be quantified.

Research hypothesis: Using a computerized prosthetic foot will provide better mobility performances: improved gait factors and center of pressure movement, decrease internal loads in the residuum and increase patient's satisfaction.

Research design:

Clinical controlled research with research group(amputees) and control group (healthy).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age: 20 to 70 years old
  • Traumatic unilateral Transtibial Amputee
  • Using Echelon foot prosthesis for at least 6 months
  • K level 3 or 4

Exclusion Criteria:

  • Injury of the sound limb that compromises the gait of the amputee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elan foot prosthesis
The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.
The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Center of pressure movement
Time Frame: 2 to 6 weeks
2 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pressure on the skin and internal loads in the residuum (measured by a surface pressure mapping technology).
Time Frame: 2 to 6 weeks
2 to 6 weeks
Grade in questionnaire for prosthetic evaluation.
Time Frame: 2 to 6 weeks
2 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Itzhak Siev-Ner, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SHEBA-13-0292-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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