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Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.

Not Applicable
Recruiting
Conditions
Healthy Volunteers
Amputee
Prostheses
Registration Number
NCT06948695
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
24
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Oxygen consumption measurementDay 1

4-minute flat run on a treadmill at comfort speed

Secondary Outcome Measures
NameTimeMethod
Stride length (in meters) of runningDay 1

Stride length of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet

Oxygen consumption measurementDay 1

4-minute up hill run (+10%), on a treadmill at comfort speed

Cadence (in steps per minute) of runningDay 2

Cadence of running according to gradient (downhill -10%, flat, uphill +10%) and type of terrain, measured during a 100-metre run on roads and paths.

Kinematic analysisDay 1

Slope-dependent kinematic analysis by measuring joint angles (in degrees), moments (Nm) and net joint forces at ankle, knee and hip (in Nm/Kg), ground reaction forces (in N/Kg) during a 1-minute run on different slopes (downhill -10%, flat, uphill +10%).

Stride length (in metres) of runningDay 2

Stride length (in metres)of running according to gradient (downhill -10%, flat, uphill +10%) and type of terrain, measured during a 100-metre run on roads and paths.

Leg muscle activity (mV)Day 1, 2

Recording of leg muscle activity under all conditions using surface electromyographic recordings (Trigno wireless electromyogram (EMG) electrodes (Delsys, Natick, USA) made on the vastus lateralis, rectus femoris and gluteus medius muscles (Root Mean Square (RMS).

Subjective sensation recordingDay 1, 2

Recording of the subjective sensation of perceived exertion at the end of each condition using a Borg scale ranging from 0 to 10.

0 = It is very very easy 10= so hard that I have to stop

Cadence of running (in steps per minutes)Day 1

Cadence of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet

Trial Locations

Locations (1)

Centre Hospitalier Universitaire

🇫🇷

Saint-Étienne, France

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