Gait and Energy Use in Children with Leg Amputations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes gait and energy expenditure in paediatric unilateral lower-limb amputees. It uses gait analysis and oxygen consumption measurements in a movement analysis lab across two sessions within a single day, plus follow-up reporting to clinicians. The aim is to describe gait patterns and how energy costs relate to walking in this population, informing clinical practice. Eligibility includes children ages 7 and older with a definitive prosthesis and no recent residual limb surgery. Data are collected during standard clinical assessments and do not involve an interventional treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Minor aged 7 and over
* Congenital (transverse agenesis with break in limb continuity) or acquired (any etiology) unilateral transfemoral or transtibial amputation. \[In the case of femoral agenesis, the flexion axis of the prosthetic knee must coincide with the contralateral one to optimize the analysis of the kinematic parameters of gait\].
* Definitive prosthesis in place (no restriction on choice of prosthetic components)
* Legal representatives not opposing participation in the study for the child

Exclusion Criteria:

* Revision surgery on the residual limb within the last 3 months
* Progressive pathology associated with amputation (unstabilized sarcoma for example) which can strongly influence walking and/or energy expenditure
* Cognitive and/or behavioral disorders that may affect compliance or test performance
* Patient already included in an interventional research protocol that could lead to bias in the present study

Where it's running

• Centre 02 - CHU Brest, Hôpital Morvan
  Brest, France Recruiting
• Centre 04 - Hospices Civils de Lyon, Hôpital Mère Enfant Groupement Hospitalier Est
  Bron, France Recruiting
• Centre 03 - CHU Dijon, Hôpital Le Bocage
  Dijon, France Recruiting
• Centre 01 - CHU de RENNES, Hôpital Pontchaillou
  Rennes, France Recruiting
• Hôpitaux Paris Est Val-de-Marne, Hôpital Saint-Maurice
  Saint-Maurice, France Recruiting
• Fondation Hopale, Centre Jacques Calvé
  Berck, France Not yet recruiting

Study contacts

• Principal investigator: Laurane Maignan-Goter — Centre 01 - CHU de RENNES, Hôpital Pontchaillou
• Study coordinator: Laurane Maignan-Goter
• Email: laurane.maignan-goter@chu-rennes.fr
• Phone: +33299284299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.