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Performance Assessement for Paralympic Athletes (PARAPERF)

21 mars 2022 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

134

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Frankrike
      • Garches, Frankrike, 92380
        • Rekrytering
        • Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Parasportives of various disciplines
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dynamic sportive activity
Tidsram: 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
Tidsram: at 42 months
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
at 42 months
Static sportive activity
Tidsram: 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
Tidsram: at 42 months
Static sportive activity: maximal speed of movement of pression center.
at 42 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Biomechanical indices of performance: isometric power measurement
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: immediately after the intervention
Blood lactatemia level will be measured by lactometer.
immediately after the intervention
VO2 peak oxygen uptake
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: through study completion, an average of 1 year
through study completion, an average of 1 year
Speed profil during the propulsion
Tidsram: through study completion, an average of 1 year
through study completion, an average of 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Utredare

  • Huvudutredare: François Genêt, MD, PhD, Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
  • Studierektor: Jean François Toussaint, MD, PhD, Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 januari 2021

Primärt slutförande (Förväntat)

1 juni 2024

Avslutad studie (Förväntat)

1 juni 2024

Studieregistreringsdatum

Först inskickad

11 december 2020

Först inskickad som uppfyllde QC-kriterierna

6 februari 2021

Första postat (Faktisk)

10 februari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • APHP201139
  • 2020-A02919-30 (Registeridentifierare: IDRCB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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