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Clinical Trial NCT07076602 (MAPEDE) for Amputation of Lower Extremity, All Causes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE) 48 Lifestyle
Clinical Trial NCT07076602 (MAPEDE) is an observational study for Amputation of Lower Extremity, All Causes and is currently not yet recruiting. Enrollment is planned to begin on September 1, 2025 and continue until the study accrues 48 participants. Led by Rennes University Hospital, this study is expected to complete by March 1, 2028. The latest data from ClinicalTrials.gov was last updated on July 22, 2025.
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 ...Show More
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 ...
Show MoreOfficial Title
Relation Between Kinematic Gait Parameters and Energy Expenditure in Children With Unilateral Lower Limb Amputation
Conditions
Amputation of Lower Extremity, All CausesOther Study IDs
- MAPEDE
- 35RC23_9872_MAPEDE
- 2024-A01990-47 (Registry Identifier) (ID-RCB_ANSM)
NCT ID Number
Start Date (Actual)
2025-09-01
Last Update Posted
2025-07-22
Completion Date (Estimated)
2028-03-01
Enrollment (Estimated)
48
Study Type
Observational
Status
Not yet recruiting
Keywords
Children
gait analysis
energy expenditure
oxygen consumption
lower extremity amputation
kinematic
psychometry
gait analysis
energy expenditure
oxygen consumption
lower extremity amputation
kinematic
psychometry
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 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.
* Durin...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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 4 questions with 5 answers to assess the degree of acceptability.
The questions are :
* During the test, did you find the sensations associated with the MASK unpleasant?
* Did you find the sensations associated with the DEVICE (COSMED) 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? | 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 three to six months post enrolment. This self-questionnaire does not have an associated score. | from 3 to 6 months post-inclusion |
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)" | Day 1 / Session 1 and Session 2 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
7 Years
Eligible Sexes
All
- 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
- 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
Study Central Contact
Contact: LAURANE MAIGNAN-GOTER, +33299284299, [email protected]
Contact: ALAIN CARO, +33299289496, [email protected]
5 Study Locations in 1 Countries
Centre 02 - CHU Brest, Hôpital Morvan, Brest, France
LAËTITIA HOUX, MD, Contact, +33298223152, [email protected]
LAËTITIA HOUX, MD, Principal Investigator
Centre 04 - Hospices Civils de Lyon, Hôpital Mère Enfant Groupement Hospitalier Est, Bron, France
MARIE-DORIANE MORARD, MD, Contact, +33679928100, [email protected]
MARIE-DORIANE MORARD, MD, Principal Investigator
Centre 03 - CHU Dijon, Hôpital Le Bocage, Dijon, France
ANAÏS GOUTERON, MD, Contact, +33380293815, [email protected]
ANAÏS GOUTERON, MD, Principal Investigator
Centre 01 - CHU de RENNES, Hôpital Pontchaillou, Rennes, France
LAURANE MAIGNAN-GOTER, Contact, +33299284299, [email protected]
LAURANE MAIGNAN-GOTER, Principal Investigator
Hôpitaux Paris Est Val-de-Marne, Hôpital Saint-Maurice, Saint-Maurice, France
NATHALY QUINTERO-PRIGENT, MD, Contact, +33143966350, [email protected]
NATHALY QUINTERO-PRIGENT, MD, Principal Investigator