Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.
NCT ID: NCT06948695
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-04-23
2026-11-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Usual blade stiffness
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).
Warm-up
5-minute warm-up run on treadmill at a freely chosen speed
Random blade test
4-minute run on a treadmill with a flat incline.
Random blade test
4-minute run on treadmill with a 10% gradient
Comfort speed test
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
Outdoor random blade test
100-metre outdoor run at a comfort speed
Less stiff blade
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).
Warm-up
5-minute warm-up run on treadmill at a freely chosen speed
Random blade test
4-minute run on a treadmill with a flat incline.
Random blade test
4-minute run on treadmill with a 10% gradient
Comfort speed test
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
Outdoor random blade test
100-metre outdoor run at a comfort speed
Stiffer blade
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).
Warm-up
5-minute warm-up run on treadmill at a freely chosen speed
Random blade test
4-minute run on a treadmill with a flat incline.
Random blade test
4-minute run on treadmill with a 10% gradient
Comfort speed test
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
Outdoor random blade test
100-metre outdoor run at a comfort speed
Interventions
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Warm-up
5-minute warm-up run on treadmill at a freely chosen speed
Random blade test
4-minute run on a treadmill with a flat incline.
Random blade test
4-minute run on treadmill with a 10% gradient
Comfort speed test
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
Outdoor random blade test
100-metre outdoor run at a comfort speed
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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David HUPIN, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Centre Hospitalier Universitaire
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A01795-42
Identifier Type: OTHER
Identifier Source: secondary_id
24CH148
Identifier Type: -
Identifier Source: org_study_id
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