NCT07076602

Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation of Lower Extremity, All Causes

Interventions

Type	Name	Description
OTHER	Gait and energy expenditure	SESSION 1: Physiotherapy assessment: clinical parameters, length of limb segments, range of motion of the lower limbs, muscle strength of each lower limb joint and trunk. Measurement of energy expenditure: 6-minute walking test with prosthesis, at a constant submaximal speed, with portable gas exchange analyzer to measure oxygen consumption and a connected device to calculate the Physiological Cost Index. * During test: recording of heart rate at the start, each minute, at the end then 5 minutes after the end, recording of the effort perceived by the child each minute (Borg scale) * At the end : questionnaire to assess child level of acceptability regarding the measurement of the O2 (Oxygen) consumption SESSION 2: Measurement of kinematic parameters by gait analysis: the child will be requested to walk with their prosthesis and shoes at spontaneous speed and at maximal gait speed. The second measurement of energy expenditure will be conducted using the same procedure as the first.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

5 sites across 1 country: France