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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01795-42 | Other Identifier | ID RCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual blade stiffness | Active Comparator | 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). |
|
| Less stiff blade | Active Comparator | 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). |
|
| Stiffer blade | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm-up | Other | 5-minute warm-up run on treadmill at a freely chosen speed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen consumption measurement | 4-minute flat run on a treadmill at comfort speed | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen consumption measurement | 4-minute up hill run (+10%), on a treadmill at comfort speed | Day 1 |
| 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%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David HUPIN, MD-PhD | Contact | (0)4 77 82 83 00 | +33 | david.hupin@chu-st-etienne.fr |
| Léonard FEASSON, MD-PhD | Contact | (0)4 77 82 83 00 | +33 | leonard.leasson@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| David HUPIN, MD-PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Recruiting | Saint-Etienne | 42055 | France |
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prospective randomized cross-over study
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| Random blade test | Other | 4-minute run on a treadmill with a flat incline. |
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| Random blade test | Other | 4-minute run on treadmill with a 10% gradient |
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| Comfort speed test | Other | 1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed. |
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| Outdoor random blade test | Other | 100-metre outdoor run at a comfort speed |
|
| Day 1 |
| 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 | Day 1 |
| 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 | Day 1 |
| Cadence (in steps per minute) of running | 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. | Day 2 |
| Stride length (in metres) of running | 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. | Day 2 |
| Leg muscle activity (mV) | 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). | Day 1, 2 |
| Subjective sensation recording | 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 | Day 1, 2 |
| ID | Term |
|---|---|
| D063996 | Warm-Up Exercise |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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