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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Oxygen consumption measurement
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Usual blade stiffness
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).
Intervention: Warm-up (Other)
Usual blade stiffness
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).
Intervention: Random blade test (Other)
Usual blade stiffness
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).
Intervention: Comfort speed test (Other)
Usual blade stiffness
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).
Intervention: Outdoor random blade test (Other)
Less stiff blade
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).
Intervention: Warm-up (Other)
Less stiff blade
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).
Intervention: Random blade test (Other)
Less stiff blade
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).
Intervention: Comfort speed test (Other)
Less stiff blade
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).
Intervention: Outdoor random blade test (Other)
Stiffer blade
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).
Intervention: Warm-up (Other)
Stiffer blade
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).
Intervention: Random blade test (Other)
Stiffer blade
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).
Intervention: Comfort speed test (Other)
Stiffer blade
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).
Intervention: Outdoor random blade test (Other)
Outcomes
Primary Outcomes
Oxygen consumption measurement
Time Frame: Day 1
4-minute flat run on a treadmill at comfort speed
Secondary Outcomes
- 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)