Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Spontaneous walking speed before and after changing or modifying the equipment
研究概览
简要总结
The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to describe any changes in these capacities. The volunteers included in this study will be testing new equipment, all of which will be CE-marked, and will therefore meet all the safety and performance conditions required for use by these patients (equipment that is likely to be prescribed as standard). These devices could benefit from current technological advances that could improve these patients' functional abilities. They will be chosen and adapted according to the volunteer's activity and current equipment.
This is a local project of the CHU Dijon Bourgogne which will take place on the Technological Investigation Platform located at the Centre de Rééducation et de Réadaptation of the CHU Dijon Bourgogne.
A maximum of 100 patients will take part in the study, divided into two sub-groups of between 5 and 50 patients, depending on the type of brace worn and the level of amputation.
After the inclusion visit, each volunteer will undergo 2 assessment visits (the order of assessment of the devices will depend on randomisation) separated by 3 to 6 weeks. Follow-up is for a maximum of 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person who has given oral consent
- •Patient able to understand simple commands and packaging instructions
- •Male or female patient over 18 years of age
- •Patient with a lower limb amputation, at tibial or femoral level
排除标准
- •Person not affiliated to or not benefiting from a social security scheme
- •Person subject to a legal protection measure (curatorship, guardianship)
- •Person subject to a judicial protection measure
- •Pregnant women, women in labour or breastfeeding mothers
- •Adults who are incapable or unable to give their consent
- •Subjects with disarticulated hips
- •Subjects with serious associated pathologies having an impact on walking (other than amputation)
研究组 & 干预措施
No change of equipment at the inclusion visit
干预措施: Quantified analysis of walking (Other)
No change of equipment at the inclusion visit
干预措施: Walk tests (Other)
No change of equipment at the inclusion visit
干预措施: Functional testing (Other)
No change of equipment at the inclusion visit
干预措施: Balance analysis (Other)
No change of equipment at the inclusion visit
干预措施: Questionnaires (Other)
Change of equipment at the end of the inclusion visit
干预措施: Walk tests (Other)
Change of equipment at the end of the inclusion visit
干预措施: Functional testing (Other)
Change of equipment at the end of the inclusion visit
干预措施: Balance analysis (Other)
Change of equipment at the end of the inclusion visit
干预措施: Quantified analysis of walking (Other)
Change of equipment at the end of the inclusion visit
干预措施: Questionnaires (Other)
结局指标
主要结局
Spontaneous walking speed before and after changing or modifying the equipment
时间窗: Up to 14 weeks
次要结局
未报告次要终点
