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

NCT ID: NCT07076602

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-03-01

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.

Conditions

Amputation of Lower Extremity, All Causes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Gait and energy expenditure

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LAURANE MAIGNAN-GOTER

Role: PRINCIPAL_INVESTIGATOR

Centre 01 - CHU de RENNES, Hôpital Pontchaillou

Locations

Centre 02 - CHU Brest, Hôpital Morvan

Brest, , France

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

Bron, , France

Centre 03 - CHU Dijon, Hôpital Le Bocage

Dijon, , France

Centre 01 - CHU de RENNES, Hôpital Pontchaillou

Rennes, , France

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

Saint-Maurice, , France

Countries

France

Central Contacts

LAURANE MAIGNAN-GOTER

Role: CONTACT

laurane.maignan-goter@chu-rennes.fr

+33299284299

ALAIN CARO

Role: CONTACT

alain.caro@chu-rennes.fr

+33299289496

Facility Contacts

LAËTITIA HOUX, MD

Role: primary

laetitia.houx@chu-brest.fr

+33298223152

MARIE-DORIANE MORARD, MD

Role: primary

marie-doriane.morard@chu-lyon.fr

+33679928100

ANAÏS GOUTERON, MD

Role: primary

anais.gouteron@chu-dijon.fr

+33380293815

LAURANE MAIGNAN-GOTER

Role: primary

laurane.maignan-goter@chu-rennes.fr

+33299284299

NATHALY QUINTERO-PRIGENT, MD

Role: primary

nathaly.quintero@ght94n.fr

+33143966350

Other Identifiers

2024-A01990-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

35RC23_9872_MAPEDE

Identifier Type: -

Identifier Source: org_study_id