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

NCT02766387 | Unknown

• 1 other identifier: 2016-A00054-47
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Amputation; Lower Extremity

Outcome Measures

Primary Outcomes (1)

• - The percentage of variance of the speed of the continuous 2km walk test and 10 meters walk test explained by the velocity estimated respectively by the 2MWT and the 6 MWT

  3 months

Study Arms (2)

2 minutes walk test

EXPERIMENTAL

fast walk test during 2 minutes in first and the 10 meters walk test, the 6 minutes walk test and the 2 kilometers walk test

Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.

6 minutes walk test

EXPERIMENTAL

comfortable walk test during 6 minutes in first and the 10 meters walk test, the 2 minutes walk test and the 2 kilometers walk test

Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.

Interventions

Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. OTHER

2 minutes walk test; 6 minutes walk test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• to be major, with a proximal lower extremity amputation (from knee disarticulation included until hemipelvectomy)
• to have a microprocessor controlled prosthetic knee among the 3C100C-leg, the RHEO Knee or HYBRID 1P360 for over a month

You may not qualify if:

• unstable angina or myocardial infarction dated less than one month,
• pregnancy or breastfeeding
• acute event responsible for a restriction in walking
• refusal to participate in the study

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05