AmputeeBLADENDURUNNCT06948695
Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.
A study testing Warm-up, Random blade test and Comfort speed test in people with Amputee and Prostheses, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputee, Prostheses, Healthy Volunteers
- What is being tested?
- Warm-up, Random blade test and Comfort speed test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2025to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputee, Prostheses, Healthy Volunteers
- Being tested
- Warm-up, Random blade test, Comfort speed test, Outdoor random blade test
- Keywords
- Unilateral transtibial amputees, Endurance runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm-upOther
5-minute warm-up run on treadmill at a freely chosen speed
Random blade testOther
4-minute run on a treadmill with a flat incline.
Random blade testOther
4-minute run on treadmill with a 10% gradient
Comfort speed testOther
1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.
Outdoor random blade testOther
100-metre outdoor run at a comfort speed
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Warm-up; Other: Random blade test; Other: Comfort speed test; Other: Outdoor random blade test |
| 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). Receives: Other: Warm-up; Other: Random blade test; Other: Comfort speed test; Other: Outdoor random blade test |
| 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). Receives: Other: Warm-up; Other: Random blade test; Other: Comfort speed test; Other: Outdoor random blade test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption measurement
4-minute flat run on a treadmill at comfort speed
Measured: Day 1
Secondary outcomes (8)
Oxygen consumption measurement
4-minute up hill run (+10%), on a treadmill at comfort speed
Measured: 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%).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Day 1, 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start23 Apr 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Why it stopped: Difficulties in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948695
- Sponsor's protocol ID
- 24CH148
- Other IDs
- 2024-A01795-42
- Acronym
- BLADENDURUN
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06948695
- Acronym / sponsor ID
- BLADENDURUN / 24CH148
- Conditions
- Amputee, Prostheses, Healthy Volunteers
- Keywords
- Unilateral transtibial amputees, Endurance runners
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in enrolling patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Usual blade stiffness | Active comparator | Other: Warm-up, Other: Random blade test, Other: Comfort speed test, Other: Outdoor random blade testData 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 | Other: Warm-up, Other: Random blade test, Other: Comfort speed test, Other: Outdoor random blade testData 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 | Other: Warm-up, Other: Random blade test, Other: Comfort speed test, Other: Outdoor random blade testData 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm-up5-minute warm-up run on treadmill at a freely chosen speed | Other | Less stiff blade, Stiffer blade, Usual blade stiffness |
| Random blade test4-minute run on a treadmill with a flat incline. | Other | Less stiff blade, Stiffer blade, Usual blade stiffness |
| Random blade test4-minute run on treadmill with a 10% gradient | Other | Less stiff blade, Stiffer blade, Usual blade stiffness |
| Comfort speed test1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed. | Other | Less stiff blade, Stiffer blade, Usual blade stiffness |
| Outdoor random blade test100-metre outdoor run at a comfort speed | Other | Less stiff blade, Stiffer blade, Usual blade stiffness |
Primary outcome
Oxygen consumption measurement
Time frame: Day 1
4-minute flat run on a treadmill at comfort speed
8 secondary outcomes
Oxygen consumption measurement
Time frame: Day 1
Kinematic analysis
Time frame: Day 1
Cadence of running (in steps per minutes)
Time frame: Day 1
Stride length (in meters) of running
Time frame: Day 1
Cadence (in steps per minute) of running
Time frame: Day 2
Stride length (in metres) of running
Time frame: Day 2
Leg muscle activity (mV)
Time frame: Day 1, 2
Subjective sensation recording
Time frame: Day 1, 2
Results and safety
The study was stopped early (reason given: Difficulties in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David HUPIN, MD-PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm-up, Random blade test and Comfort speed test in people with Amputee and Prostheses, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in enrolling patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption measurement (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.