NCT07432776 Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design
| NCT ID | NCT07432776 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Penn State University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-02-02 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver. The main questions it aims to answer are: 1. Does participating in the pickleball program improve sensory-motor function (including visual-motor integration and proprioceptive bias), measured using the HaptiKart task and a pickleball skill assessment? 2. Does participating in the pickleball program reduce core autism symptom severity, measured by the Social Responsiveness Scale, 2nd edition (SRS-2)? Researchers will compare an early-start pickleball group to a delayed-start control group (who continues usual activities at first) to see if the pickleball program leads to greater improvements in sensory-motor outcomes and ASD symptom severity. Participants will: * Complete an in-person baseline visit at a local public library to provide written consent, complete surveys (SRS-2, PROMIS Depression and Sleep measures, and WHOQOL-BREF), and complete a video game-based sensory-motor assessment (HaptiKart). * Be randomly assigned to either start pickleball classes immediately or after an initial delay period. * Attend pickleball classes twice per week for 8 weeks (90 minutes per class; 16 sessions total), led by trained instructors at community indoor court facilities. * Continue their usual activities during periods when they are not assigned to pickleball classes. * Complete a brief pickleball skill assessment during the intervention period at their first and last class. * Complete follow-up assessments after each phase of the study to repeat surveys and sensory-motor testing. * Participants will also wear a small activity monitor (ActiGraph) during pickleball sessions to measure in-class physical activity levels, and complete brief online check-ins about safety/injury and program feedback during the intervention period.
Eligibility Criteria
Inclusion Criteria: * Aged 18-45 years * Clinical diagnosis of autism spectrum disorder (ASD) * Able to participate in group-based activities without caregiver support * Able to understand English and independently communicate without assistance * Available for at least two sessions per week for the intervention dates * Access to reliable transportation to the intervention site * Able to provide informed consent (i.e., no legally authorized representative) * Pre-exercise screening indicates medical clearance is not needed, based on ACSM guidelines Exclusion Criteria: * Clinical diagnosis of intellectual disability (ID) * Does not have normal or corrected-to-normal vision * Actively participating in a racquet sport ≥1 time per week * Use of mobility aids * Moderate-to-severe joint pain (WOMAC pain subscale) * Neurologic conditions (cerebral palsy, severe head injury, progressive neurological disorders, epilepsy) * Individuals who cannot provide their own informed consent (i.e., have a legally authorized representative) * Individuals who require medical clearance for exercise based on the ACSM preparticipation screening questionnaire
Contact & Investigator
Chris Sciammana, MD
PRINCIPAL INVESTIGATOR
Penn State College of Medicine
Frequently Asked Questions
Who can join the NCT07432776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07432776 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07432776 currently recruiting?
Yes, NCT07432776 is actively recruiting participants. Visit ClinicalTrials.gov or contact Penn State University to inquire about joining.
Where is the NCT07432776 trial being conducted?
This trial is being conducted at Middletown, United States.
Who is sponsoring the NCT07432776 clinical trial?
NCT07432776 is sponsored by Penn State University. The principal investigator is Chris Sciammana, MD at Penn State College of Medicine. The trial plans to enroll 50 participants.