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Recruiting

NCT Number: NCT05110729

Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury

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

Recruiting

Interested in participating?

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location status: Recruiting

Location contact

Emily Sweeney, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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(

Treatment and study plan

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 1 day Initial Visit

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: At follow up visit, up to 3 months post initial visit

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 1 day (At clearance visit to return to sport)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 6-months post initial visit

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 12-months post initial visit

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

  6. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Time frame: Assessed at 1 day initial visit

    Questionnaire designed to assess patient fear of movement.

  7. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Time frame: At follow up visit, up to 3 months post initial visit

    Questionnaire designed to assess patient fear of movement.

  8. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Time frame: 1 day (At clearance visit to return to sport)

    Questionnaire designed to assess patient fear of movement.

  9. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Time frame: 6-months post initial visit

    Questionnaire designed to assess patient fear of movement.

  10. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Time frame: 12-months post initial visit

    Questionnaire designed to assess patient fear of movement.

Secondary outcomes

  1. Injury location and type questionnaire

    Time frame: 1 day Initial visit

    Patient-reported details of their musculoskeletal injury, including injury location and type. Also asks for details regarding the participant's pain rating, duration of pain, and the impact the injury has on sport participation.

  2. Level of Specialization

    Time frame: 1 day (At clearance visit to return to sport)

    Questionnaire designed to identify an athlete's level of sport specialization.

  3. Level of Specialization

    Time frame: 6-months post initial visit

    Questionnaire designed to identify an athlete's level of sport specialization.

  4. Level of Specialization

    Time frame: 12-months post initial visit

    Questionnaire designed to identify an athlete's level of sport specialization.

  5. Injury History

    Time frame: Assessed at the patient's 1 day initial visit.

    Patient-reported history of previous musculoskeletal injuries.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Assessed at initial 1 day visit

    Questionnaire used to determine the participant's quality of sleep.

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At follow up visit, up to 3 months post initial visit

    Questionnaire used to determine the participant's quality of sleep.

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 1 day (At clearance visit to return to sport)

    Questionnaire used to determine the participant's quality of sleep.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6-months post initial visit

    Questionnaire used to determine the participant's quality of sleep.

  10. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12-months post initial visit

    Questionnaire used to determine the participant's quality of sleep.

Study contacts

Contact information is provided by the study sponsor or research team.

Casey Little, BS

CONTACT

[email protected]

7207770109

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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