Validation of the SIGAM/VF Mobility Grade

Amputation Clinical Trial

— SIGAM  

Official title:

Validation of the SIGAM/VF Mobility Grade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859740
• Other study ID #: GREMEAUX JOUSSAIN 2013-3
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 4, 2016
• Start date: August 2013

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• SIGAM Questionnaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Answers to the SIGAM mobility scale questionnaire		Change from baseline at Week 2 and Week 3	No