Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05110729

Conditions

Musculoskeletal Injury

Quality of Life

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study aims to assess the quality and life and life satisfaction of pediatric and adolescent gymnasts throughout their musculoskeletal injury recovery.

Conditions

Musculoskeletal Injury

Quality of Life

Study ID

NCT05110729

Start date

Nov 12, 2021

Status verified date

Apr, 2024

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female gymnasts ages 8-18 years old
  • Participating in Excel or Developmental gymnastics programs who present to Children's Hospital Colorado sports medicine or orthopedic clinics with a musculoskeletal injury.

Exclusion Criteria:

  • Gymnasts only participating in Colorado Association for Recreational Athletics (CARA) gymnastics, retired gymnasts, and adult or collegiate gymnasts.
  • Vulnerable populations (prisoners, pregnant women, individuals with decreased decision making capacity(

Study Design

Enrollment

1218 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 1 day Initial Visit ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: At follow up visit, up to 3 months post initial visit ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 1 day (At clearance visit to return to sport) ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 6-months post initial visit ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 12-months post initial visit ]
  • Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: Assessed at 1 day initial visit ]
  • Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: At follow up visit, up to 3 months post initial visit ]
  • Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 1 day (At clearance visit to return to sport) ]
  • Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 6-months post initial visit ]
  • Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 12-months post initial visit ]

Central Contacts and Locations

Central contacts

Casey Little, BS

7207770109casey.little@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Emily Sweeney, MD

emily.sweeney@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Keywords

  • Gymnastics
  • Quality of Life and Life Satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-04-02.