Relation Between Kinematic Gait Parameters and Energy Expenditure in Children With Unilateral Lower Limb Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 13
- 主要终点
- Identification of oxygen cost of walking in children with lower limb amputation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Gait and energy expenditure (Other)
结局指标
主要结局
Identification of oxygen cost of walking in children with lower limb amputation
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Validation of the Physiological Cost Index (PCI) for the energy expenditure analysis in clinical routine(Day 1 / Session 1 and Session 2)
- Usefulness of informations provided by the energy expenditure measurement and gait analysis assessed by a self-questionnaire(from 3 to 6 months post-inclusion)
- 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(through study completion)
- Validation of the Physiological Cost Index (PCI) for the energy expenditure analysis in clinical routine(Day 1)