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Validation of the SIGAM/VF Mobility Grade

Validation of the SIGAM/VF Mobility Grade

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02859740
Acronym
SIGAM
Enrollment
70
Registered
2016-08-09
Start date
2013-08-31
Completion date
Unknown
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

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.

Interventions

OTHERSIGAM Questionnaire

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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…)

Design outcomes

Primary

MeasureTime frame
Answers to the SIGAM mobility scale questionnaireChange from baseline at Week 2 and Week 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026