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NCT Number: NCT06507072

Adaptive Rock Climbing

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.

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Key information

Conditions

Congenital Upper Limb Differences Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Upper Extremity Deformities, Congenital

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Abigail Padilla

CONTACT

[email protected]

3236602450 ext. 4730

Nina Lightdale, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Rock Climbing Program

Behavioral

Twelve week rock climbing program. The program will take place once per week over the course of twelve weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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."

  5. 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."

Secondary outcomes

  1. Assess Barriers to Participation in Adaptive Sports

    Time frame: At 12 weeks (post-intervention)

    Identify common transportation barriers through a demographic survey with transportation questions.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Padilla

CONTACT

[email protected]

3236602450 ext. 4730

Abigail Padilla

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

Evaluating Adaptive Rock Climbing on Children With Upper Limb Differences

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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