RECRUITING

Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.

Official Title

Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

Quick Facts

Study Start:2023-01-30
Study Completion:2026-01-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mitchell Selhorst, DPT, PhD
CONTACT
6143559764
Mitchell.Selhorst@Nationwidechildrens.org

Principal Investigator

Mitchell Selhorst, DPT, PhD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Nationwide Children's Hospital Sports and Ortho Physical Therapy
Columbus, Ohio, 43215
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Mitchell Selhorst, DPT, PhD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-30
Study Completion Date2026-01-23

Study Record Updates

Study Start Date2023-01-30
Study Completion Date2026-01-23

Terms related to this study

Keywords Provided by Researchers

  • Adolescent
  • Atraumatic
  • Education
  • Patellofemoral
  • Tendinopathy
  • Apophysitis
  • Overuse

Additional Relevant MeSH Terms

  • Leg Injury