Amputee, Healthy Volunteers, Prostheses
Conditions
Keywords
Unilateral transtibial amputees, Endurance runners
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.
Interventions
OTHERWarm-up
5-minute warm-up run on treadmill at a freely chosen speed
OTHERRandom blade test
4-minute run on a treadmill with a flat incline.
OTHERComfort speed test
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
OTHEROutdoor random blade test
100-metre outdoor run at a comfort speed
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
prospective randomized cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen consumption measurement | Day 1 | 4-minute flat run on a treadmill at comfort speed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinematic analysis | 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%). |
| Cadence of running (in steps per minutes) | Day 1 | Cadence of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet |
| Stride length (in meters) of running | 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 |
| Oxygen consumption measurement | Day 1 | 4-minute up hill run (+10%), on a treadmill at comfort speed |
| Stride length (in metres) of running | 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. |
| Leg muscle activity (mV) | 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). |
| Subjective sensation recording | 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 |
| Cadence (in steps per minute) of running | 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. |
Countries
France
Contacts
Primary ContactDavid HUPIN, MD-PhD
Backup ContactLéonard FEASSON, MD-PhD
Outcome results
None listed