NCT04748497

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.4 years

First QC Date

December 11, 2020

Last Update Submit

March 21, 2022

Conditions

Keywords

paralympic athletesperformance

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (14)

  • Biomechanical indices of performance: isometric power measurement

    through study completion, an average of 1 year

  • Biomechanical indices of performance: arms and shoulder's Strength

    through study completion, an average of 1 year

  • Physiological indices of performance: maximal aerobic speed (MAS)

    Twice through study completion, an average of 42 months

  • Physiological indices of performance: maximal aerobic power

    Twice through study completion, an average of 42 months

  • Fatigue assessment

    Twice through study completion, an average of 42 months

  • +9 more secondary outcomes

Study Arms (1)

Parasportives of various disciplines

OTHER
Other: Standardization of evaluation and follow-up

Interventions

Standardization of evaluation and clinical and sportive follow-up of athletes. Made-to-measure technical supports will be tested regarding the Paralympic regulations.

Parasportives of various disciplines

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP

Garches, 92380, France

RECRUITING

Study Officials

  • François Genêt, MD, PhD

    Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP

    PRINCIPAL INVESTIGATOR
  • Jean François Toussaint, MD, PhD

    Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP

    STUDY DIRECTOR

Central Study Contacts

Jean François Toussaint, MD, PhD

CONTACT

François Genêt, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

February 10, 2021

Study Start

January 8, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations