Performance Assessement for Paralympic Athletes (PARAPERF)

March 21, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic sportive activity
Time Frame: through study completion, an average of 1 year
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
through study completion, an average of 1 year
Dynamic sportive activity
Time Frame: at 42 months
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
at 42 months
Static sportive activity
Time Frame: through study completion, an average of 1 year
Static sportive activity: maximal speed of movement of pression center.
through study completion, an average of 1 year
Static sportive activity
Time Frame: at 42 months
Static sportive activity: maximal speed of movement of pression center.
at 42 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biomechanical indices of performance: isometric power measurement
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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)
Time Frame: Twice through study completion, an average of 42 months
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
Time Frame: Twice through study completion, an average of 42 months
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
Time Frame: Twice through study completion, an average of 42 months
Fatigue assessment will be measured by Fatigue Index (Power max ratio).
Twice through study completion, an average of 42 months
Blood lactate concentration
Time Frame: immediately after the intervention
Blood lactatemia level will be measured by lactometer.
immediately after the intervention
VO2 peak oxygen uptake
Time Frame: through study completion, an average of 1 year
VO2 peak oxygen uptake
through study completion, an average of 1 year
Peak breath expiration volume assessment
Time Frame: through study completion, an average of 1 year
VE peak: peak breath expiration volume
through study completion, an average of 1 year
Peak cardiac frequence
Time Frame: through study completion, an average of 1 year
CF: peak cardiac frequence
through study completion, an average of 1 year
Musculo-squeletic troubles risks measurement
Time Frame: through study completion, an average of 1 year
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 Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
Applied forces on handrim during the propulsion: measured by force platform.
through study completion, an average of 1 year
Acceleration profil during the propulsion
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Speed profil during the propulsion
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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