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

NCT07076602 | Not Yet Recruiting

• 2 other identifiers: 35RC23_9872_MAPEDE2024-A01990-47
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Amputation of Lower Extremity, All Causes

Keywords

Children; gait analysis; energy expenditure; oxygen consumption; lower extremity amputation; kinematic; psychometry

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• 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.

  Day 1

Secondary Outcomes (5)

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

  Day 1

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

  Day 1

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

  Day 1

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

  from 3 to 6 months post-inclusion

• Validation of the Physiological Cost Index (PCI) for the energy expenditure analysis in clinical routine

  Day 1 / Session 1 and Session 2

Study Arms (1)

Gait and energy expenditure

Inclusion of a single day comprising two sessions of 2.5 hours each (both sessions can be interchanged) SESSION 1 : Physiotherapy assessment + Measurement of energy expenditure SESSION 2 : Measurement of kinematic parameters by gait analysis + Measurement of energy expenditure

Other: Gait and energy expenditure

Interventions

Gait and energy expenditure OTHER

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.

Gait and energy expenditure

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (5)

Centre 02 - CHU Brest, Hôpital Morvan

Brest, France

Location

Centre 04 - Hospices Civils de Lyon, Hôpital Mère Enfant Groupement Hospitalier Est

Bron, France

Location

Centre 03 - CHU Dijon, Hôpital Le Bocage

Dijon, France

Location

Centre 01 - CHU de RENNES, Hôpital Pontchaillou

Rennes, France

Location

Hôpitaux Paris Est Val-de-Marne, Hôpital Saint-Maurice

Saint-Maurice, France

Location

MeSH Terms

Interventions

Gait; Energy Metabolism

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Metabolism

Study Officials

• LAURANE MAIGNAN-GOTER

  Centre 01 - CHU de RENNES, Hôpital Pontchaillou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURANE MAIGNAN-GOTER

CONTACT

+33299284299; laurane.maignan-goter@chu-rennes.fr

ALAIN CARO

CONTACT

+33299289496; alain.caro@chu-rennes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)