跳至主要内容
临床试验/NCT06948695
NCT06948695招募中不适用

Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees According to the Stiffness of the Race-specific Prothesis.

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Oxygen consumption measurement

研究概览

简要总结

Transtibial amputation accounts for 3,700 cases per year in France. Athletes can use sport blades made of carbon plate for improved energy restitution.

Sports blades are adjusted according to the manufacturer's recommendations and the subjective experience of the ortho-prosthetist and patient. These adjustments are designed to optimize performance and comfort while reducing the risk of injury. This risk is all the greater when asymmetries between the healthy and affected limbs are large, exposing the healthy limb to large and repeated reaction forces.

详细描述

Furthermore, one of the performance criteria for long-distance running is energy cost. While a reduction in this parameter has been observed in bilateral amputees, heterogeneous data are reported in unilateral amputees, depending on the level of expertise and sports blade settings.

While studies have investigated the effects of running with a prosthesis under conditions representative of track running, few data are available on sports blades designed for long-distance running.

It therefore seems important to be able to objectively assess the effects of a change in the stiffness of the sports blade on the energetics and biomechanics of running, in order to optimize practice and prevent associated traumas.

Secondly, investigators believe it is important to verify that the biomechanical results obtained in the laboratory are applicable in the field, both on the road and on the unstable terrain encountered by trail runners.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female,
  • •Weighing less than 110 kg, in accordance with C-blade recommendations,
  • •Subjects who have undergone a unilateral transtibial amputation,
  • •Have been running with a sports blade for at least 3 months, over several sessions of at least 3 kilometers.
  • •Subjects who have signed a written consent form,
  • •Subjects affiliated or entitled to a social security scheme.

排除标准

  • •Subjects whose amputation is due to complications related to diabetes or atherosclerosis.
  • •Subjects with chronic or central neurological pathologies
  • •Subjects with cardiovascular disorders
  • •Subjects with alcohol or drug dependency.
  • •Pregnant or breast-feeding women
  • •Subjects under court protection.

研究组 & 干预措施

Usual blade stiffness

Active Comparator

Data collection on a blade with usual stiffness during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Warm-up (Other)

Usual blade stiffness

Active Comparator

Data collection on a blade with usual stiffness during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Random blade test (Other)

Usual blade stiffness

Active Comparator

Data collection on a blade with usual stiffness during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Comfort speed test (Other)

Usual blade stiffness

Active Comparator

Data collection on a blade with usual stiffness during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Outdoor random blade test (Other)

Less stiff blade

Active Comparator

Data collection on a less stiff blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Warm-up (Other)

Less stiff blade

Active Comparator

Data collection on a less stiff blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Random blade test (Other)

Less stiff blade

Active Comparator

Data collection on a less stiff blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Comfort speed test (Other)

Less stiff blade

Active Comparator

Data collection on a less stiff blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Outdoor random blade test (Other)

Stiffer blade

Active Comparator

Data collection on a stiffer blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Warm-up (Other)

Stiffer blade

Active Comparator

Data collection on a stiffer blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Random blade test (Other)

Stiffer blade

Active Comparator

Data collection on a stiffer blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Comfort speed test (Other)

Stiffer blade

Active Comparator

Data collection on a stiffer blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).

干预措施: Outdoor random blade test (Other)

结局指标

主要结局

Oxygen consumption measurement

时间窗: Day 1

4-minute flat run on a treadmill at comfort speed

次要结局

  • Cadence of running (in steps per minutes)(Day 1)
  • Stride length (in meters) of running(Day 1)
  • Oxygen consumption measurement(Day 1)
  • Cadence (in steps per minute) of running(Day 2)
  • Kinematic analysis(Day 1)
  • Stride length (in metres) of running(Day 2)
  • Leg muscle activity (mV)(Day 1, 2)
  • Subjective sensation recording(Day 1, 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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