Evaluation of Correlations Between Different Walk Tests in Patients With

Status Enrolling by invitation

Clinical Trial Summary

Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the amputation. About microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking speed changes. They are indicated in the proximal amputations of the lower limbs from knee disarticulation included. Their prescription can only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk down the stairs step by step. These criteria must be validated after a minimum trial period of 15 days.

These attribution criteria raise the question today of how they are measured, no recommendation defining this procedure. While many standardized assessment tests of different gait parameters are available and used in clinical research, the attribution criteria are not being built in reference to these tests.

The overall objective of the study is to evaluate the diagnostic value of two simple clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02766387
Study type	Interventional
Source	University Hospital, Angers
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	May 2016
Completion date	October 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Correlations Between Different Walk Tests in Patients With Transfemoral Amputees

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms