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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05110729
Other study ID # 21-4271
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 12, 2021
Est. completion date November 2026

Study information

Verified date April 2024
Source University of Colorado, Denver
Contact Casey Little, BS
Phone 7207770109
Email casey.little@childrenscolorado.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 1218
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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


Locations

Country Name City State
United States Children's Hospital Colorado Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (15)

Beleckas CM, Prather H, Guattery J, Wright M, Kelly M, Calfee RP. Anxiety in the orthopedic patient: using PROMIS to assess mental health. Qual Life Res. 2018 Sep;27(9):2275-2282. doi: 10.1007/s11136-018-1867-7. Epub 2018 May 8. — View Citation

Chang C, Putukian M, Aerni G, Diamond A, Hong G, Ingram Y, Reardon CL, Wolanin A. Mental health issues and psychological factors in athletes: detection, management, effect on performance and prevention: American Medical Society for Sports Medicine Position Statement-Executive Summary. Br J Sports Med. 2020 Feb;54(4):216-220. doi: 10.1136/bjsports-2019-101583. Epub 2019 Dec 6. — View Citation

Filbay S, Pandya T, Thomas B, McKay C, Adams J, Arden N. Quality of Life and Life Satisfaction in Former Athletes: A Systematic Review and Meta-Analysis. Sports Med. 2019 Nov;49(11):1723-1738. doi: 10.1007/s40279-019-01163-0. — View Citation

Hart E, Meehan WP 3rd, Bae DS, d'Hemecourt P, Stracciolini A. The Young Injured Gymnast: A Literature Review and Discussion. Curr Sports Med Rep. 2018 Nov;17(11):366-375. doi: 10.1249/JSR.0000000000000536. — View Citation

Jayanthi NA, Post EG, Laury TC, Fabricant PD. Health Consequences of Youth Sport Specialization. J Athl Train. 2019 Oct;54(10):1040-1049. doi: 10.4085/1062-6050-380-18. — View Citation

Li H, Moreland JJ, Peek-Asa C, Yang J. Preseason Anxiety and Depressive Symptoms and Prospective Injury Risk in Collegiate Athletes. Am J Sports Med. 2017 Jul;45(9):2148-2155. doi: 10.1177/0363546517702847. Epub 2017 Apr 25. — View Citation

Lim SW, Shiue YL, Ho CH, Yu SC, Kao PH, Wang JJ, Kuo JR. Anxiety and Depression in Patients with Traumatic Spinal Cord Injury: A Nationwide Population-Based Cohort Study. PLoS One. 2017 Jan 12;12(1):e0169623. doi: 10.1371/journal.pone.0169623. eCollection 2017. — View Citation

Mainwaring LM, Hutchison M, Bisschop SM, Comper P, Richards DW. Emotional response to sport concussion compared to ACL injury. Brain Inj. 2010;24(4):589-97. doi: 10.3109/02699051003610508. — View Citation

Mauck B, Kelly D, Sheffer B, Rambo A, Calandruccio JH. Gymnast's Wrist (Distal Radial Physeal Stress Syndrome). Orthop Clin North Am. 2020 Oct;51(4):493-497. doi: 10.1016/j.ocl.2020.06.012. Epub 2020 Aug 13. — View Citation

McGuine TA, Winterstein A, Carr K, Hetzel S, Scott J. Changes in self-reported knee function and health-related quality of life after knee injury in female athletes. Clin J Sport Med. 2012 Jul;22(4):334-40. doi: 10.1097/JSM.0b013e318257a40b. — View Citation

Pasulka J, Jayanthi N, McCann A, Dugas LR, LaBella C. Specialization patterns across various youth sports and relationship to injury risk. Phys Sportsmed. 2017 Sep;45(3):344-352. doi: 10.1080/00913847.2017.1313077. Epub 2017 Apr 10. — View Citation

Pluhar E, McCracken C, Griffith KL, Christino MA, Sugimoto D, Meehan WP 3rd. Team Sport Athletes May Be Less Likely To Suffer Anxiety or Depression than Individual Sport Athletes. J Sports Sci Med. 2019 Aug 1;18(3):490-496. eCollection 2019 Sep. — View Citation

Putukian M. The psychological response to injury in student athletes: a narrative review with a focus on mental health. Br J Sports Med. 2016 Feb;50(3):145-8. doi: 10.1136/bjsports-2015-095586. Epub 2015 Dec 30. — View Citation

Valovich McLeod TC, Bay RC, Parsons JT, Sauers EL, Snyder AR. Recent injury and health-related quality of life in adolescent athletes. J Athl Train. 2009 Nov-Dec;44(6):603-10. doi: 10.4085/1062-6050-44.6.603. — View Citation

Xanthopoulos MS, Benton T, Lewis J, Case JA, Master CL. Mental Health in the Young Athlete. Curr Psychiatry Rep. 2020 Sep 21;22(11):63. doi: 10.1007/s11920-020-01185-w. Erratum In: Curr Psychiatry Rep. 2020 Oct 2;22(12):64. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations. 1 day Initial Visit
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations. At follow up visit, up to 3 months post initial visit
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations. 1 day (At clearance visit to return to sport)
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations. 6-months post initial visit
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations. 12-months post initial visit
Primary Tampa Scale for Kinesiophobia-11 (TSK-11) Questionnaire designed to assess patient fear of movement. Assessed at 1 day initial visit
Primary Tampa Scale for Kinesiophobia-11 (TSK-11) Questionnaire designed to assess patient fear of movement. At follow up visit, up to 3 months post initial visit
Primary Tampa Scale for Kinesiophobia-11 (TSK-11) Questionnaire designed to assess patient fear of movement. 1 day (At clearance visit to return to sport)
Primary Tampa Scale for Kinesiophobia-11 (TSK-11) Questionnaire designed to assess patient fear of movement. 6-months post initial visit
Primary Tampa Scale for Kinesiophobia-11 (TSK-11) Questionnaire designed to assess patient fear of movement. 12-months post initial visit
Secondary Injury location and type questionnaire 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. 1 day Initial visit
Secondary Level of Specialization Questionnaire designed to identify an athlete's level of sport specialization. 1 day (At clearance visit to return to sport)
Secondary Level of Specialization Questionnaire designed to identify an athlete's level of sport specialization. 6-months post initial visit
Secondary Level of Specialization Questionnaire designed to identify an athlete's level of sport specialization. 12-months post initial visit
Secondary Injury History Patient-reported history of previous musculoskeletal injuries. Assessed at the patient's 1 day initial visit.
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire used to determine the participant's quality of sleep. Assessed at initial 1 day visit
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire used to determine the participant's quality of sleep. At follow up visit, up to 3 months post initial visit
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire used to determine the participant's quality of sleep. 1 day (At clearance visit to return to sport)
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire used to determine the participant's quality of sleep. 6-months post initial visit
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire used to determine the participant's quality of sleep. 12-months post initial visit
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