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Behavioural Intervention
Exercise for Communication Disorders
N/A
Recruiting
Led By Jenya Iuzzini-Seigel, PhD
Research Sponsored by Marquette University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post each treatment session (n = 18) up to 6 weeks.
Summary
This trial aims to understand the fitness levels and motor abilities of children with Developmental Language Disorder (DLD). DLD affects 1 in 13 children and often leads to poorer motor skills. The
Who is the study for?
This trial is for children with developmental language disorder (DLD) and those with typical development. It aims to see if exercise improves learning, fitness, and motor skills compared to restful play. Children must be able to participate in physical activities or calm play sessions three times a week for six weeks.
What is being tested?
The study tests whether an exercise program involving cardiovascular, agility, balance, strength, and endurance training can benefit children's learning and motor skills more than restful activities like playing with legos or coloring.
What are the potential side effects?
There are no specific side effects mentioned for the interventions in this trial; however, general risks may include potential injury from physical activity or stress from participating in structured tasks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds)
Changes to cognitive-linguistic performance: Word learning accuracy (% correct)
Secondary study objectives
Enjoyment of Intervention
Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)
Motor Performance (scaled scores)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExerciseExperimental Treatment1 Intervention
This group will receive treatment 3x/week for 6 weeks
Group II: Restful PlayPlacebo Group1 Intervention
This group will receive treatment 3x/week for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820
Find a Location
Who is running the clinical trial?
Marquette UniversityLead Sponsor
63 Previous Clinical Trials
200,409 Total Patients Enrolled
University of ArizonaOTHER
534 Previous Clinical Trials
159,435 Total Patients Enrolled
Jenya Iuzzini-Seigel, PhDPrincipal InvestigatorMarquette University
1 Previous Clinical Trials
60 Total Patients Enrolled
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