Congenital Upper Limb DifferencesNCT06507072
Adaptive Rock Climbing
A study testing Adaptive Rock Climbing Program in people with Congenital Upper Limb Differences, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Congenital Upper Limb Differences
- What is being tested?
- Adaptive Rock Climbing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abigail Padilla contact
United States1 site, 1 recruiting
- Recruiting
Children Hospital Los Angeles
Los Angeles, California, 90027
Abigail Padilla, 3236602450 ext. 4730, abpadilla@chla.usc.edu
Nina Lightdale, MD
About this study
Official title: 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.
- Conditions
- Congenital Upper Limb Differences
- Being tested
- Adaptive Rock Climbing Program
- Keywords
- Adaptive sports, Rock climbing, Congenital Upper Limb Differences, Improved psychosocial health
- Medical subject headings
- Upper Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Rock Climbing ProgramBehavioural
Twelve week rock climbing program. The program will take place once per week over the course of twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Rock Climbing | Experimental | Not described Receives: Behavioral: Adaptive Rock Climbing Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Assess Barriers to Participation in Adaptive Sports
Identify common transportation barriers through a demographic survey with transportation questions.
Measured: At 12 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start6 Dec 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Upper Limb DifferencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Lightdale, Children's Hospital Los Angeles
- Investigators
- Nina Lightdale, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507072
- Sponsor's protocol ID
- CHLA-24-00150
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Adaptive Rock Climbing on Children With Upper Limb Differences
- ClinicalTrials.gov ID
- NCT06507072
- Acronym / sponsor ID
- CHLA-24-00150
- Conditions
- Congenital Upper Limb Differences
- Keywords
- Adaptive sports, Rock climbing, Congenital Upper Limb Differences, Improved psychosocial health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Rock Climbing | Experimental | Behavioral: Adaptive Rock Climbing Program |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Rock Climbing ProgramTwelve week rock climbing program. The program will take place once per week over the course of twelve weeks. | Behavioural | Adaptive Rock Climbing |
Primary outcome
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."
1 secondary outcome
Assess Barriers to Participation in Adaptive Sports
Time frame: At 12 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Congenital Upper Limb Differences
Recruiting
Level Up! Adaptive Gaming for Children With Upper Limb Differences
Upper Limb Amputation at the Wrist, Pediatric
Recruiting
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
Amputation, Amputation, Traumatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abigail Padilla contact
Nina Lightdale, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Rock Climbing Program in people with Congenital Upper Limb Differences, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Padilla (3236602450 ext. 4730, abpadilla@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Range of Motion at 12 Weeks (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.