Performance Assessement for Paralympic Athletes (PARAPERF)

Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports

The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.

The secondary objectives of the study:

• quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
• quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
• quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
• quantification and mechanical monitoring by the made-to-measure or usual sportive material.

Study Overview

• Status: Recruiting
• Conditions: Paralympic Athletes; Sportive Performance
• Intervention / Treatment: Other: Standardization of evaluation and follow-up

Detailed Description

The sportive performance results from a range of determinations such as: physiological, biomechanical, morphological, psychological, social and environmental factors. The interactions between athletes, equipment, training and environment influences the development of athletes' performance. In the context of the coming Paris 2024 Paralympic Games, the performance construction for the exploration, the quantification and the management of all factors is an commun objective between sportive team, medical team and researchers.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean François Toussaint, MD, PhD; Phone Number: +33 (0)1 42 34 82 10; Email: jean-francois.toussaint@aphp.fr
• Study Contact Backup: Name: François Genêt, MD, PhD; Phone Number: +33 (0)1.47.10.70.68; Email: francois.genet@aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• High-lever paralympic athletes registered on the ministerial list or selected by Parasport Federation of France or Shooting Federation of France;
• Aged >= 14 years;
• Informed consent signed by adult athlete or by holder of parental authority or guardian for minor athlete;
• Covered by social security system.

Exclusion Criteria:

• Temporary or definitive contraindication to the practice of the affected sport activity;
• Undergoing anti-coagulated treatments;
• Cognitive disabilities conducting impossibility to participating to clinical trial, such as serious cognitive troubles, behaviors troubles, psychic troubles or upgraded curatorship needing;
• Under guardianship or judicial decision;
• Ongoing pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Parasportives of various disciplines	Other: Standardization of evaluation and follow-up; Standardization of evaluation and clinical and sportive follow-up of athletes. Made-to-measure technical supports will be tested regarding the Paralympic regulations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic sportive activity	Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.	through study completion, an average of 1 year
Dynamic sportive activity	Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.	at 42 months
Static sportive activity	Static sportive activity: maximal speed of movement of pression center.	through study completion, an average of 1 year
Static sportive activity	Static sportive activity: maximal speed of movement of pression center.	at 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanical indices of performance: isometric power measurement	Isometric power will be measured by MicroFet & handgrip of 26 measures, advice for healthcare professionals to measure handgrip strength forces to test and document grip deficits and to evaluate consistency of effort.	through study completion, an average of 1 year
Biomechanical indices of performance: arms and shoulder's Strength	Arms and shoulder's Strength will be measured by force platform.	through study completion, an average of 1 year
Physiological indices of performance: maximal aerobic speed (MAS)	Maximal aerobic speed (MAS) will be measured by Repetition Per Minute on a Arm ergometer.	Twice through study completion, an average of 42 months
Physiological indices of performance: maximal aerobic power	Maximal aerobic power will be measured by following Watts fluctuation during the incremental hand-biking test.	Twice through study completion, an average of 42 months
Fatigue assessment	Fatigue assessment will be measured by Fatigue Index (Power max ratio).	Twice through study completion, an average of 42 months
Blood lactate concentration	Blood lactatemia level will be measured by lactometer.	immediately after the intervention
VO2 peak oxygen uptake	VO2 peak oxygen uptake	through study completion, an average of 1 year
Peak breath expiration volume assessment	VE peak: peak breath expiration volume	through study completion, an average of 1 year
Peak cardiac frequence	CF: peak cardiac frequence	through study completion, an average of 1 year
Musculo-squeletic troubles risks measurement	Musculo-squeletic troubles risks will be measured by medical following and clinical method of functional assessment of the shoulder (i.e. "Constant scale").	through study completion, an average of 1 year
Time and distance of deceleration of wheelchair during riding test	Time and distance of deceleration of wheelchair during riding test: measured by signal analysis of instrumented wheelchair (inertial control units).	through study completion, an average of 1 year
Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion	Applied forces on handrim during the propulsion: measured by force platform.	through study completion, an average of 1 year
Acceleration profil during the propulsion		through study completion, an average of 1 year
Speed profil during the propulsion		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Genêt, MD, PhD, Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP; Study Director: Jean François Toussaint, MD, PhD, Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: performance; paralympic athletes
• Other Study ID Numbers: APHP201139; 2020-A02919-30 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No