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ClinicalTrials.gov ID

NCT07076602

Lead Sponsor

Rennes University HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

48Estimated

Last Update Posted

Jul 22, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Mar 1, 2028Estimated

Official Title

Relation Between Kinematic Gait Parameters and Energy Expenditure in Children With Unilateral Lower Limb Amputation

Brief Summary

In lower limb amputation, prosthetic gait has been shown to be particularly energy-intensive. While energy expenditure has been the focus of many studies in adult amputees, this area of research is less developed for paediatric amputees. However, the increase in energy expenditure has implications for the physical, gait, and balance abilities of amputees of all ages. Combined with physical deconditioning, it exposes the patient to a greater risk of a sedentary lifestyle and weight gain, which is detrimental to their prosthetic training, autonomy, and length of hospital stay. However, this increased expenditure and deconditioning is not currently the subject of systematic evaluation in routine clinical practice for this population. In contrast to adults, the gait pattern of children amputees is poorly described, and the relation between energy expenditure and gait is rarely discussed. Oxygen consumption is the most widely used outcome to assess energy expenditure in studies. The main aim of this study was to identify the kinematic gait parameters obtained by quantified gait analysis associated with oxygen consumption during a 6-minute test in children with lower-limb amputations aged 7 years or older. This study also makes it possible to evaluate with the child's physician and rehabilitators the usefulness of measuring energy expenditure to guide medical decisions and rehabilitative care. Finally, it will allow the validation of a tool for this population for measuring energy expenditure that has been presented as more easily applicable in clinical routine than the measurement of oxygen consumption, the Physiological Cost Index (PCI). The validity and reliability of the PCI will therefore be evaluated. This study will therefore facilitate the assessment and monitoring of child amputees and provide guidance for the provision of an evidence-based rehabilitation program.

Detailed Description

The selection of subjects is carried out by the doctor of the center to which the child is attached. After obtaining consent, the study will be conducted in the movement analysis laboratory of the recruiting center, over the course of one day, comprising two sessions of 2.5 hours each. This study visit is separate from routine follow-up care.

One session will include a physiotherapy assessment and the evaluation of energy expenditure (oxygen consumption and Physiological Cost Index PCI) during a of 6-minute walking test.

The other session will include the assessment of kinematic parameters during a gait analysis and again the assessment of energy expenditure during a of 6-minute walking test.

FOLLOW-UP VISIT The report of all tests carried out will be made available to the child's physician and physiotherapists. An electronic questionnaire will be sent to them three to six months following the child' inclusion, to assess the usefulness of the information provided by the energy expenditure measurement and gait analysis in their practice.

• Amputation of Lower Extremity, All Causes

• Gait and energy expenditure

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Minor aged 7 and over
• Congenital (transverse agenesis with break in limb continuity) or acquired (any etiology) 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
• Patient already included in an interventional research protocol that could lead to bias in the present study

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Rennes University HospitalOTHER

anais.gouteron@chu-dijon.fr+33380293815