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OpenTrials
Completed

NCT Number: NCT02859740

Validation of the SIGAM/VF Mobility Grade

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

SIGAM Questionnaire

Other

Primary outcomes

  1. Answers to the SIGAM mobility scale questionnaire

    Time frame: Change from baseline at Week 2 and Week 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: SIGAM

Important dates

Study start
2013
Primary completion
2014
First posted
Aug 9, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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