NCT06507072 · Children's Hospital Los Angeles
Adaptive Rock Climbing
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Adaptive Rock Climbing Program
Twelve week rock climbing program. The program will take place once per week over the course of twelve weeks.
Primary outcome measures
Change from Baseline in Range of Motion at 12 Weeks
Time frame: Baseline and 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.
Change from Baseline in KINDL Scores at 12 Weeks
Time frame: Baseline and 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.
Change from Baseline in Muscle Testing at 12 Weeks.
Time frame: Baseline and 12 weeks
Manual muscle testing will be measured by an occupational therapist. This will be measured from grade 0 to 5.
Change from Baseline in PROMIS Life Satisfaction Scores at 12 Weeks.
Time frame: Baseline and 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."
Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks
Time frame: Baseline and 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."
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2025 · Source of record for eligibility and locations