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NCT Number: NCT06948695

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

David HUPIN, MD-PhD

CONTACT

[email protected]

(0)4 77 82 83 00 ext. +33

David HUPIN, MD-PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warm-up

Other

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

Random blade test

Other

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

Comfort speed test

Other

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

Outdoor random blade test

Other

100-metre outdoor run at a comfort speed

Primary outcomes

  1. Oxygen consumption measurement

    Time frame: Day 1

    4-minute flat run on a treadmill at comfort speed

Secondary outcomes

  1. Oxygen consumption measurement

    Time frame: Day 1

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

  2. Kinematic analysis

    Time frame: Day 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%).

  3. Cadence of running (in steps per minutes)

    Time frame: Day 1

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

  4. Stride length (in meters) of running

    Time frame: Day 1

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

  5. Cadence (in steps per minute) of running

    Time frame: Day 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.

  6. Stride length (in metres) of running

    Time frame: Day 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.

  7. Leg muscle activity (mV)

    Time frame: 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).

  8. Subjective sensation recording

    Time frame: Day 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

Study contacts

Contact information is provided by the study sponsor or research team.

David HUPIN, MD-PhD

CONTACT

[email protected]

(0)4 77 82 83 00 ext. +33

Léonard FEASSON, MD-PhD

CONTACT

[email protected]

(0)4 77 82 83 00 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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.

Acronym: BLADENDURUN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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