Amputation of Lower Extremity, All CausesMAPEDENCT07076602
Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)
An observational study of Amputation of Lower Extremity, All Causes, run by Rennes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Amputation of Lower Extremity, All Causes
- What is being tested?
- Gait and energy expenditure
- How many people
- 48 participants
- Where
- 8 sitesFrance
- Study dates
- 13 Oct 2025to 13 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Fondation Hopale, Centre Jacques Calvé
Berck, 62600
Paul POTEL, MD, +33321893194, paul.potel@fondation-hopale.org
Paul POTEL, MD
- Recruiting
Centre 02 - CHU Brest, Hôpital Morvan
Brest
LAËTITIA HOUX, MD, +33298223152, laetitia.houx@chu-brest.fr
LAËTITIA HOUX, MD
- Recruiting
Centre 04 - Hospices Civils de Lyon, Hôpital Mère Enfant Groupement Hospitalier Est
Bron
CAROLE VUILLEROT, MD, +33472129504, carole.vuillerot@chu-lyon.fr
CAROLE VUILLEROT, MD
- Recruiting
Centre 03 - CHU Dijon, Hôpital Le Bocage
Dijon
ANAÏS GOUTERON, MD, +33380293815, anais.gouteron@chu-dijon.fr
ANAÏS GOUTERON, MD
- Not yet recruiting
Centre 08 - Croix-Rouge Française, Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69322
Laure BOUTEVILLAIN, MD, +33472381888, laura.boutevillain@croix-rouge.fr
Laure BOUTEVILLAIN, MD
- Recruiting
Centre 01 - CHU de RENNES, Hôpital Pontchaillou
Rennes
LAURANE MAIGNAN-GOTER, +33299284299, laurane.maignan-goter@chu-rennes.fr
LAURANE MAIGNAN-GOTER
- Recruiting
Hôpitaux Paris Est Val-de-Marne, Hôpital Saint-Maurice
Saint-Maurice
NATHALY QUINTERO-PRIGENT, MD, +33143966350, nathaly.quintero@ght94n.fr
NATHALY QUINTERO-PRIGENT, MD
- Not yet recruiting
Centre 06 - Institut Robert Merle d'Aubigné, IRMA Valenton
Valenton, 94460
Brice LAVRARD, MD, +33145108405, b.lavrard@irma-valenton.fr
Brice LAVRARD, MD
About this study
Official title: Relation Between Kinematic Gait Parameters and Energy Expenditure in Children With Unilateral Lower Limb Amputation
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.
Read the 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 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 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 at the end of each center's inclusion period, to assess the usefulness of the information provided by the energy expenditure measurement and gait analysis in their practice.
- Being tested
- Gait and energy expenditure
- Keywords
- Children, gait analysis, energy expenditure, oxygen consumption, lower extremity amputation, kinematic, psychometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait and energy expenditureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Gait and energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (5)
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.
Measured: Day 1
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.
Measured: Day 1
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?
Measured: Day 1
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.
Measured: through study completion
Validation of the Physiological Cost Index (PCI) for the energy expenditure analysis in clinical routine
PCI formula : "PCI (beat/m) = [end Hearth Rate (HR) - Rest HR (beat/min)] / walking speed at the last minute of the 6 minutes walking test (m/min)"
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start13 Oct 2025
- Primary completion13 Oct 2027 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Lower Extremity, All CausesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURANE MAIGNAN-GOTER, Principal investigator, Centre 01 - CHU de RENNES, Hôpital Pontchaillou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076602
- Sponsor's protocol ID
- 35RC23_9872_MAPEDE
- Other IDs
- 2024-A01990-47
- Acronym
- MAPEDE
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Kinematic Gait Parameters and Energy Expenditure in Children With Unilateral Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT07076602
- Acronym / sponsor ID
- MAPEDE / 35RC23_9872_MAPEDE
- Keywords
- Children, gait analysis, energy expenditure, oxygen consumption, lower extremity amputation, kinematic, psychometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 13 Oct 2027 (estimated)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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 at the end of each center's inclusion period, to assess the usefulness of the information provided by the energy expenditure measurement and gait analysis in their practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait and energy expenditure | – | Other: Gait and energy expenditureInclusion 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 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait and energy expenditureSESSION 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. | Other | Gait and energy expenditure |
Primary outcome
Identification of oxygen cost of walking in children with lower limb amputation
Time frame: Day 1
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.
Identification of gait parameters in children with lower limb amputation
Time frame: Day 1
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.
5 secondary outcomes
Identification of the determinants of oxygen cost of walking among clinical parameters of the children with lower limb amputation
Time frame: Day 1
Perceived effort of the procedure for measuring oxygen consumption during the walking test assessed by the modified Borg scale
Time frame: Day 1
Acceptability of the procedure for measuring the children's oxygen consumption when walking assessed by a self-questionnaire
Time frame: Day 1
Usefulness of informations provided by the energy expenditure measurement and gait analysis assessed by a self-questionnaire
Time frame: through study completion
Validation of the Physiological Cost Index (PCI) for the energy expenditure analysis in clinical routine
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LAURANE MAIGNAN-GOTER principal investigator
Centre 01 - CHU de RENNES, Hôpital Pontchaillou
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation of Lower Extremity, All Causes, run by Rennes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURANE MAIGNAN-GOTER (+33299284299, laurane.maignan-goter@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of oxygen cost of walking in children with lower limb amputation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.