Adaptive Rock Climbing

Evaluating Adaptive Rock Climbing on Children with Upper Limb Differences

The goal of this clinical trial is to assess changes in functional and psychosocial outcomes following a 12-week adaptive rock-climbing program for children with congenital upper limb differences. The main questions it aims to answer are

• Assess functional outcomes following a 12-week adaptive rock-climbing program.
• Assess psychosocial outcomes following a 12-week adaptive rock climbing program.
• Assess barriers to participation in adaptive sports.

Participants will complete 12-week adaptive rock climbing program.

Study Overview

• Status: Recruiting
• Conditions: Congenital Upper Limb Differences
• Intervention / Treatment: Behavioral: Adaptive Rock Climbing Program

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Padilla; Phone Number: 4730 3236602450; Email: abpadilla@chla.usc.edu
• Study Contact Backup: Name: Abigail Padilla; Email: orthoresearch@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children Hospital Los Angeles
      • Contact: Abigail Padilla; Phone Number: 4730 3236602450; Email: abpadilla@chla.usc.edu
      • Contact: Nina Lightdale, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parents 18 years and older.
• English or Spanish speaking.
• Participants with unilateral or bilateral congenital upper extremity disorders of limb formation differences ages 6-16.

Exclusion Criteria:

• Any patients younger than 6 years or older than 16 years, patients not fluent in English or Spanish, or patients with parents younger than 18 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive Rock Climbing	Behavioral: Adaptive Rock Climbing Program; Twelve week rock climbing program. The program will take place once per week over the course of twelve weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Range of Motion at 12 Weeks	An occupational therapist will measure the passive and active range of motion. These measurements will be conducted for the following: shoulder flexion, shoulder abduction, shoulder internal rotation, shoulder external rotation, elbow flexion/extension, forearm supination, forearm pronation, wrist extension, and wrist flexion. This will be measured in degrees.	Baseline and 12 weeks
Change from Baseline in KINDL Scores at 12 Weeks	The KINDL questionnaire will be completed by both child and parent. It includes 24 Likert-scaled items associated with emotional well-being and self-esteem. Questionnaires will be scored according to instructions provided by KINDL.	Baseline and 12 weeks
Change from Baseline in Muscle Testing at 12 Weeks.	Manual muscle testing will be measured by an occupational therapist. This will be measured from grade 0 to 5.	Baseline and 12 weeks
Change from Baseline in PROMIS Life Satisfaction Scores at 12 Weeks.	To assess positive affect and well-being, children and parents will complete the PROMIS Pediatric Life Satisfactions v1.0 8-item Short Form. Patients will respond to statements such as "I was satisfied with my life," on a scale of 1 "Not at all" to 5 "Very much."	Baseline and 12 weeks
Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks	To gain a general view of participants' perception of their own physical, emotional, and relational health, children will also be asked to complete the PROMIS Pediatric Global Health v1.0 7-item Short Form. Participants will respond to 7 statements on a scale of 5 "Excellent" to 1 "Poor."	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Barriers to Participation in Adaptive Sports	Identify common transportation barriers through a demographic survey with transportation questions.	At 12 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Nina Lightdale, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Rock climbing; Adaptive sports; Congenital Upper Limb Differences; Improved psychosocial health
• Other Study ID Numbers: CHLA-24-00150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No