Studies

Interventional Terminated

NCT06948695 on ClinicalTrials.gov

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

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.

  • Sponsor: Centre Hospitalier Universitaire de Saint-Etienne
  • Enrollment: 10 (Actual)
  • Study start: 2025-04-23 (Actual)
  • Primary completion: 2025-11-24 (Actual)
  • Study completion: 2025-11-24 (Actual)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: prospective randomized cross-over study
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Amputee
  • Prostheses
  • Healthy Volunteers

Intervention / Treatment

  • Other: Warm-up
  • Other: Random blade test
  • Other: Comfort speed test
  • Other: Outdoor random blade test

Primary Outcome Measures

  • Oxygen consumption measurement (Day 1)
    4-minute flat run on a treadmill at comfort speed

Countries

France

Locations and Investigators

  • Centre Hospitalier Universitaire, Saint-Etienne, France

Study Officials