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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Warm-up

    Other intervention

    5-minute warm-up run on treadmill at a freely chosen speed

  • Random blade test

    Other intervention

    4-minute run on a treadmill with a flat incline.

  • Random blade test

    Other intervention

    4-minute run on treadmill with a 10% gradient

  • Comfort speed test

    Other intervention

    1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.

  • Outdoor random blade test

    Other intervention

    100-metre outdoor run at a comfort speed

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Usual blade stiffnessActive comparator 4 interventions
Group B: Less stiff bladeActive comparator 4 interventions
Group C: Stiffer bladeActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Oxygen consumption measurement

4-minute flat run on a treadmill at comfort speed

Time frame
Day 1

Secondary outcomes

1

Oxygen consumption measurement

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

Time frame
Day 1
2

Kinematic analysis

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%).

Time frame
Day 1
3

Cadence of running (in steps per minutes)

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

Time frame
Day 1
4

Stride length (in meters) of running

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

Time frame
Day 1

Other outcomes

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