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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Amputee; Healthy Volunteers; Prostheses

Treatments: Other: Warm-up; Other: Comfort speed test; Other: Outdoor random blade test; Other: Random blade test

Study type: Interventional

Funder types: Other

Identifiers

NCT06948695

2024-A01795-42 (Other Identifier)

24CH148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Usual blade stiffness

Active Comparator group

Description:

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).

Treatment:

Other: Random blade test

Other: Outdoor random blade test

Other: Comfort speed test

Other: Warm-up

Other: Random blade test

Less stiff blade

Active Comparator group

Description:

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).

Treatment:

Other: Random blade test

Other: Outdoor random blade test

Other: Comfort speed test

Other: Warm-up

Other: Random blade test

Stiffer blade

Active Comparator group

Description:

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).

Treatment:

Other: Random blade test

Other: Outdoor random blade test

Other: Comfort speed test

Other: Warm-up

Other: Random blade test