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Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

Phase 2
Completed
Conditions
Vascular Diseases
Registration Number
NCT00616668
Lead Sponsor
Sheba Medical Center
Brief Summary

The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.

Detailed Description

The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.

In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Transtibial amputees due to vascular diseases.
Exclusion Criteria
  • Bilateral amputation.
  • Upper extremity can't bear weight.
  • The sound leg can't bear weight.
  • Amputee that needs Dialysis treatment.
  • Cognitive impairment.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.1-4 month
The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.2-6 month
Secondary Outcome Measures
NameTimeMethod
The duration of stump healing and functional status of transtibial amputees.1-6 month
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