Clinical trial NCT06948695: Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputee
Prostheses
Healthy Volunteers
Keywords: Unilateral transtibial amputees
Endurance runners
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomized cross-over study
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygen consumption measurement
timeFrame: Day 1
Secondary outcomes:
measure: Oxygen consumption measurement
timeFrame: Day 1
measure: Kinematic analysis
timeFrame: Day 1
measure: Cadence of running (in steps per minutes)
timeFrame: Day 1
measure: Stride length (in meters) of running
timeFrame: Day 1
measure: Cadence (in steps per minute) of running
timeFrame: Day 2
measure: Stride length (in metres) of running
timeFrame: Day 2
measure: Leg muscle activity (mV)
timeFrame: Day 1, 2
measure: Subjective sensation recording
timeFrame: Day 1, 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: