Clinical trial NCT02859740: Validation of the SIGAM/VF Mobility Grade
Official title: Validation of the SIGAM/VF Mobility Grade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with temporary or permanent prosthesis

Brief 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.


Eligibility criteria: 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...)

Primary outcomes:
measure: Answers to the SIGAM mobility scale questionnaire
timeFrame: Change from baseline at Week 2 and Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: