Centre Hospitalier Universitaire
Saint-Etienne, 42055, France
Location status: Recruiting
NCT Number: NCT06948695
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Saint-Etienne, 42055, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5-minute warm-up run on treadmill at a freely chosen speed
4-minute run on a treadmill with a flat incline.
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
100-metre outdoor run at a comfort speed
Time frame: Day 1
4-minute flat run on a treadmill at comfort speed
Time frame: Day 1
4-minute up hill run (+10%), on a treadmill at comfort speed
Time frame: 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%).
Time frame: Day 1
Cadence of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Contact information is provided by the study sponsor or research team.
David HUPIN, MD-PhD
CONTACT
(0)4 77 82 83 00 ext. +33
Léonard FEASSON, MD-PhD
CONTACT
(0)4 77 82 83 00 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
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.
Acronym: BLADENDURUN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07613502
Amputation, Amputation of Lower Limb Above Knee
Jacksonville, Florida, United States
View Trial DetailsNCT06849934
Amputee, Amputees
Ankara, Turkey (Türkiye)
View Trial DetailsNCT04330274
Amputee, Balance
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03825432
Amputee, Behavior
Mersin, Turkey (Türkiye)
View Trial Details