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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Prostheses; Amputee
• Intervention / Treatment: Other: Warm-up; Other: Random blade test; Other: Random blade test; Other: Comfort speed test; Other: Outdoor random blade test

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David HUPIN, MD-PhD; Phone Number: +33 (0)4 77 82 83 00; Email: david.hupin@chu-st-etienne.fr
• Study Contact Backup: Name: Léonard FEASSON, MD-PhD; Phone Number: +33 (0)4 77 82 83 00; Email: leonard.leasson@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire
    • Contact: David HUPIN, MD-PhD; Phone Number: +33 (0)4 77 82 83 00; Email: david.hupin@chu-st-etienne.fr
    • Principal Investigator: David HUPIN, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: Warm-up; 5-minute warm-up run on treadmill at a freely chosen speed; Other: Random blade test; 4-minute run on a treadmill with a flat incline.; Other: Random blade test; 4-minute run on treadmill with a 10% gradient; Other: Comfort speed test; 1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.; Other: Outdoor random blade test; 100-metre outdoor run at a comfort speed
Active Comparator: 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).	Other: Warm-up; 5-minute warm-up run on treadmill at a freely chosen speed; Other: Random blade test; 4-minute run on a treadmill with a flat incline.; Other: Random blade test; 4-minute run on treadmill with a 10% gradient; Other: Comfort speed test; 1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.; Other: Outdoor random blade test; 100-metre outdoor run at a comfort speed
Active Comparator: 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).	Other: Warm-up; 5-minute warm-up run on treadmill at a freely chosen speed; Other: Random blade test; 4-minute run on a treadmill with a flat incline.; Other: Random blade test; 4-minute run on treadmill with a 10% gradient; Other: Comfort speed test; 1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.; Other: Outdoor random blade test; 100-metre outdoor run at a comfort speed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen consumption measurement	4-minute flat run on a treadmill at comfort speed	Day 1

Secondary Outcome Measures

Outcome Measure	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%).	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, MD-PhD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Endurance runners; Unilateral transtibial amputees
• Additional Relevant MeSH Terms: Dermatologic Agents; Keratolytic Agents; Pyrithione zinc
• Other Study ID Numbers: 24CH148; 2024-A01795-42 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No