NCT06948695

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Apr 2025Nov 2026

First Submitted

Initial submission to the registry

February 7, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

February 7, 2025

Last Update Submit

August 4, 2025

Conditions

AmputeeProsthesesHealthy Volunteers

Keywords

Unilateral transtibial amputeesEndurance runners

Outcome Measures

Primary Outcomes (1)

  • Oxygen consumption measurement

    4-minute flat run on a treadmill at comfort speed

    Day 1

Secondary Outcomes (8)

  • Oxygen consumption measurement

    Day 1

  • Kinematic analysis

    Day 1

  • Cadence of running (in steps per minutes)

    Day 1

  • Stride length (in meters) of running

    Day 1

  • Cadence (in steps per minute) of running

    Day 2

  • +3 more secondary outcomes

Study Arms (3)

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).

Other: Warm-upOther: Random blade testOther: Comfort speed testOther: 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).

Other: Warm-upOther: Random blade testOther: Comfort speed testOther: 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).

Other: Warm-upOther: Random blade testOther: Comfort speed testOther: Outdoor random blade test

Interventions

Warm-upOTHER

5-minute warm-up run on treadmill at a freely chosen speed

Less stiff bladeStiffer bladeUsual blade stiffness
Random blade testOTHER

4-minute run on a treadmill with a flat incline.

Less stiff bladeStiffer bladeUsual blade stiffness
Comfort speed testOTHER

1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.

Less stiff bladeStiffer bladeUsual blade stiffness
Outdoor random blade testOTHER

100-metre outdoor run at a comfort speed

Less stiff bladeStiffer bladeUsual blade stiffness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Interventions

Warm-Up Exercise

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David HUPIN, MD-PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD-PhD

CONTACT

(0)4 77 82 83 00david.hupin@chu-st-etienne.fr

Léonard FEASSON, MD-PhD

CONTACT

(0)4 77 82 83 00leonard.leasson@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: prospective randomized cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

April 29, 2025

Study Start

April 23, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations

FR(1)