Validation of the SIGAM/VF Mobility Grade (SIGAM)

August 4, 2016 updated by: Centre Hospitalier Universitaire Dijon
The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with temporary or permanent prosthesis

Description

Inclusion Criteria:

  • Aged 18 to 80 years
  • Patients who have been informed about the research
  • Patients with national health insurance cover
  • Patients who accepted to take part in the study
  • Able to understand simple instructions
  • With transtibial, femoral, or bilateral amputation of the lower limb
  • Whatever the etiology
  • Patients able to do the 2-minute walk test

  • Group 1:

    • Patients in the stabilized phase of the definitive prosthesis, with no modification of the prosthesis in the previous 3 months and at more than 6 months after the amputation.

  • Group 2:

    • Patients in the initial phase of management (temporary prosthesis, rehabilitation) post trans-tibial unilateral amputation

Exclusion Criteria:

  • Patient without national health insurance cover.
  • Patients under guardianship.
  • Pregnant or breast-feeding women.
  • Alteration of executive functions making understanding of and compliance with the research protocol impossible (Mini Mental State Examination<20)
  • Associated chronic motor deficiency, of neurological origin (examples: sequelae of stroke, balance and coordination disorders), or of osteo-articular origin (examples: knee or hip osteoarthritis), or due to secondary functional repercussions making it impossible to walk with a prosthesis.
  • Severe medical disorder that significantly impairs functional capacities (severe heart failure, respiratory failure, non-stabilized metabolic disorders such as progressive kidney failure) that is life-threatening in the short or medium term (Progressive neoplastic disease, non-stabilized systemic disease).
  • Complications at the stump other than microcirculation that could affect the application of a contact socket/sleeve: haematoma, Cysts, effusion, calcifications of soft tissues, bone spurs, infection (skin, abscess), neuroma, deterioration of the knee of the amputated limb, specifically painful Farabeuf angle (compression between bone and skin), venous thrombosis, abnormal stump shape making it impossible to use a socket (flexion of the knee, "pear-shaped", "deep-scar" stump…)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
permanent prosthesis
Other: SIGAM Questionnaire
Temporary prosthesis
Other: SIGAM Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Answers to the SIGAM mobility scale questionnaire
Time Frame: Change from baseline at Week 2 and Week 3
Change from baseline at Week 2 and Week 3

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GREMEAUX JOUSSAIN 2013-3

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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