Clinical trial NCT05110729: Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury
Official title: Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Injury
Quality of Life
Keywords: Gymnastics
Quality of Life and Life Satisfaction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 1218
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from Children's Hospital Colorado Sports medicine and Orthopedic outpatient clinics.

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


Eligibility criteria: 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(

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 1 day Initial Visit
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At follow up visit, up to 3 months post initial visit
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 1 day (At clearance visit to return to sport)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6-months post initial visit
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 12-months post initial visit
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: Assessed at 1 day initial visit
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: At follow up visit, up to 3 months post initial visit
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 1 day (At clearance visit to return to sport)
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 6-months post initial visit
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 12-months post initial visit
Secondary outcomes:
measure: Injury location and type questionnaire
timeFrame: 1 day Initial visit
measure: Level of Specialization
timeFrame: 1 day (At clearance visit to return to sport)
measure: Level of Specialization
timeFrame: 6-months post initial visit
measure: Level of Specialization
timeFrame: 12-months post initial visit
measure: Injury History
timeFrame: Assessed at the patient's 1 day initial visit.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Assessed at initial 1 day visit
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At follow up visit, up to 3 months post initial visit
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 day (At clearance visit to return to sport)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6-months post initial visit
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12-months post initial visit
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Emily Sweeney, MD
role: PRINCIPAL_INVESTIGATOR
References:
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