About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants will be drawn from the active caseload of pediatric patients with limb amputation who are currently under regular follow-up at the participating centers. These patients are monitored as part of routine clinical care. Only those meeting the predefined eligibility criteria (outlined elsewhere in the record) will be considered for inclusion. As such, the study population will reflect children and adolescents with limb amputation managed in specialized healthcare settings.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Gait and energy expenditure
Other intervention
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 start, at end then 5 minutes after end, recording of the effort perceived by the child at start, at end then 5 minutes after (Borg scale) * At 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.

Treatment groups

48 Participants

are divided into 1 treatment group

Group A: Gait and energy expenditure1 intervention

Trial outcomes

Primary outcomes

1

Identification of oxygen cost of walking in children with lower limb amputation

Oxygen cost of walking (mL.kg-1.m-1): ratio of oxygen flow rate (mL.kg-1.s-1) and walking speed (m.s-1) during 6-minute walking test. Oxygen flow rate is computed as the difference in oxygen concentration between inhaled and exhaled air during a breath. It is measured per breath and averaged over a 6-minute walking test.

Time frame

Day 1

2

Identification of gait parameters in children with lower limb amputation

Gait parameters are defined by : * deviation from a healthy pediatric norm available in the gait analysis software averaged over the entire gait cycle, calculated for the trunk, pelvis, hips, knees and ankles in each plane of space * deviation of center of gravity position relative to theorical position at constant speed. Spatiotemporal parameters include : speed, cadence, step length (on both sides) and stride width.

Time frame

Day 1

Secondary outcomes

1

Identification of the determinants of oxygen cost of walking among clinical parameters of the children with lower limb amputation

Oxygen cost of walking (mL.kg-1.m-1) : ratio of oxygen flow rate (mL.kg-1.s-1) and walking speed (m.s-1) during 6-minute walking test. Oxygen flow rate is computed as the difference in oxygen concentration between inhaled and exhaled air during a breath. It is measured per breath and averaged over a 6-minute walking test. Clinical parameters : age, sex, height, weight, level and age of amputation.

Time frame

Day 1

2

Perceived effort of the procedure for measuring oxygen consumption during the walking test assessed by the modified Borg scale

Modified Borg Rating of perceived exertion scales: the minimum score is 6 meaning very, very light effort, the maximum score is 10 indicating the maximum exertion.

Time frame

Day 1

3

Acceptability of the procedure for measuring the children's oxygen consumption when walking assessed by a self-questionnaire

This self-questionnaire designed for the study consists of 5 questions to assess the degree of acceptability. The questions are : * During the test, did you find the sensations associated with the MASK on your face unpleasant? * Did you find the sensations associated with the DEVICE (COSMED) behind your back unpleasant? * Did you feel comfortable and well supported by the examiner during the test? * Would you be willing to take this test again if we offered it to you? * Do you have any specific comments?

Time frame

Day 1

4

Usefulness of informations provided by the energy expenditure measurement and gait analysis assessed by a self-questionnaire

This self-questionnaire named "Assessment of the study's clinical impact" and specially designed for the study will be addressed to the child's physician, physiotherapist or/and orthoprosthetist of the children amputees to assess the impact of energy expenditure measurement and gait analysis in guiding medical decisions and rehabilitative care at the end of each center's inclusion period. This self-questionnaire does not have an associated score.

Time frame

through study completion

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts