An interventional study of Exercise and Restful Play in Developmental Language Disorder, sponsored by Marquette University. Recruiting at 1 site in United States. Open to participants aged 5 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Marquette University · Not applicable, Interventional, and Treatment
This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities.
All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs.
Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color.
Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program.
Communication impairments affect \~10% of children in the US between 3-10 years of age, and fine/gross motor deficits co-occur in an astounding 30-85% of this population. One subpopulation that evidences high rates of co-occurring language and motor deficits is children with developmental language disorder (DLD; a highly common disorder that affects expressive and/or receptive language in 1/13 children). Consequently, millions of children present with these debilitating impairments that require time-consuming and costly therapy, which typically occurs in discipline-specific silos. The siloed approach has limitations as it fails to leverage potentially synergistic effects that may be achieved when the whole child is treated, rather than intervene discipline by discipline.
Alternative, ground-shifting interventions that harness neuroplasticity and yield multisystem gains are needed to fill this gap in treatment options for children with co-occurring language and motor deficits.
The goal of the proposed research is two-fold. The Aim 1 study will establish motor performance and fitness levels for children with DLD and carefully characterize the motor deficits of children in this population. The Aim 2 study is a Phase 0/Early Phase 1 random control trial (RCT) that tests the efficacy of physical exercise as treatment to promote cognitive-linguistic and fitness gains in children with DLD. Participants will be randomly assigned to undergo 6 weeks (3x/week) of exercise training (i.e., activities to train cardiovascular fitness, agility, balance, strength, endurance) or to a restful play condition (e.g., legos and coloring) on the same schedule. Both interventions will be provided in small groups. Cognitive-linguistic and fitness will be assessed pre-treatment and again immediately post treatment and at 1-month, and 3-months post treatment to determine treatment and maintenance gains on these measures.
This research will gather vital information for a Phase 2 trial of preliminary efficacy and contribute high-quality evidence that will help speech language pathologists and other practitioners make evidence-based clinical decisions. The long-term goal of this research program is to identify the breadth of comorbid impairments in children with communication disorders and develop optimally effective treatments to maximize outcomes and quality of life for the millions of children and families coping with communication impairments.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →Marquette University is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
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Inclusion Criteria:
Children with a diagnosis of developmental language disorder (DLD) or typically developing controls will be included.
All children will meet following inclusion criteria:
Exclusion Criteria:
Exclusionary Criteria are:
This group will receive treatment 3x/week for 6 weeks
Behavioral: Exercise
This group will receive treatment 3x/week for 6 weeks.
Behavioral: Restful Play
Participants will participate in cardiovascular, agility, balance, strength and coordination training.
This group will engage in restful play activities such as coloring and playing with legos.
Changes to cognitive-linguistic performance: Word learning accuracy (% correct)
Participants will complete a word learning task in which they are taught novel words and then tested on their recognition of the novel words. Accuracy on this task will be assessed at various time points. This task has previously been used to test effects of a brief bout of exercise (3 minutes) on word learning accuracy for children in the same age range.
Time frame: Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)
Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds)
The Serial Reaction Time task is a procedural learning task that tests learning of a 5-step visuospatial sequence. It has previously been used to demonstrate procedural learning gains and differences in children with childhood apraxia of speech, phonological disorder, language disorder, and typical development.
Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)
VO2 max (ml/kg/min) will be used to establish fitness level to address Aim 1 and will be used to measure changes to fitness for Aim 2. This will be collected based on performance on the Progressive Aerobic Cardiovascular Endurance Run (PACER).
Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Motor Performance (scaled scores)
Motor Performance on the Movement Assessment Battery for Children, which yields scaled component scores for manual dexterity, balance, and aiming and catching. Each component score has a mean of 10 with scores below 7 indicating performance below the age-expected typically developing range.
Time frame: pre-treatment, immediately post-treatment
Enjoyment of Intervention
Enjoyment will be measured on a 5-point smiley face pictorial likert scale that ranges from negative to neutral to positive. Children will complete this following each intervention session.
Time frame: Immediately post each treatment session (n = 18) up to 6 weeks.
Plan to share: Yes — Deidentified individual level data will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 6 months after publication. No end date.
Access criteria: Researchers who provide a methodologically sound proposal and evidence of ethical conduct of research and appropriate institutional oversight (e.g., IRB). Proposals should be directed to jenya.iuzzini-seigel@marquette.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.
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