Developmental Language DisorderNCT06340893
Exercise Training in Children With Communication Impairments
A study testing Exercise and Restful Play in people with Developmental Language Disorder, run by Marquette University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- Exercise and Restful Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 15 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with a diagnosis of developmental language disorder (DLD) or typically developing controls will be included.
- All children will meet following inclusion criteria:
- (1) between 5 and 9 years old at enrollment
- (2) from homes where the primary language spoken is English
- (3) normal hearing based on parent report and audiometric screening
- (4) typical nonverbal cognition as determined by a T-score within 1.5 standard deviations of the mean on nonverbal subtests of the Reynolds Intellectual Assessment Scales
Who cannot join
- Exclusionary Criteria are:
- (1) diagnosis of disorder that significantly affects social interactions (e.g., autism), as per referral diagnosis or which is identified during initial screening or assessment phase
- (2) vision impairments that prevent participation in our experimental protocol
- (3) inability for any reason to participate in assessment and/or treatment protocols
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danielle Rice contact
United States1 site, 1 recruiting
- Recruiting
Marquette U
Milwaukee, Wisconsin, 53201
Jenya Iuzzini-Seigel, PhD, 5854894683, jenya.iuzzini-seigel@marquette.edu
About this study
Official title: Exercise as Treatment in Children With Communication Impairments
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Developmental Language Disorder
- Being tested
- Exercise, Restful Play
- Keywords
- developmental language disorder, exercise, learning, word learning, fitness
- Medical subject headings
- Language Development Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will participate in cardiovascular, agility, balance, strength and coordination training.
Restful PlayBehavioural
This group will engage in restful play activities such as coloring and playing with legos.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This group will receive treatment 3x/week for 6 weeks Receives: Behavioral: Exercise |
| Restful Play | Sham comparator | This group will receive treatment 3x/week for 6 weeks. Receives: Behavioral: Restful Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Immediately post each treatment session (n = 18) up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start2 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Developmental Language DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Jenya Iuzzini-Seigel, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340893
- Sponsor's protocol ID
- 76117
- Status last verified
- May 2025
- First submitted
- 8 Mar 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual level data will be shared
Publications
Iuzzini-Seigel J, Moorer L, Tamplain P. An Investigation of Developmental Coordination Disorder Characteristics in Children With Childhood Apraxia of Speech. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):1006-1021. doi: 10.1044/2022_LSHSS-21-00163. Epub 2022 Aug 30.
PubMed 36041512Iuzzini-Seigel J. Motor Performance in Children With Childhood Apraxia of Speech and Speech Sound Disorders. J Speech Lang Hear Res. 2019 Sep 20;62(9):3220-3233. doi: 10.1044/2019_JSLHR-S-18-0380. Epub 2019 Sep 3.
PubMed 31479382Iuzzini-Seigel J. Procedural Learning, Grammar, and Motor Skills in Children With Childhood Apraxia of Speech, Speech Sound Disorder, and Typically Developing Speech. J Speech Lang Hear Res. 2021 Apr 14;64(4):1081-1103. doi: 10.1044/2020_JSLHR-20-00581. Epub 2021 Mar 30.
PubMed 33784194Zelaznik HN, Goffman L. Generalized motor abilities and timing behavior in children with specific language impairment. J Speech Lang Hear Res. 2010 Apr;53(2):383-93. doi: 10.1044/1092-4388(2009/08-0204).
PubMed 20360463Castelli DM, Hillman CH, Buck SM, Erwin HE. Physical fitness and academic achievement in third- and fifth-grade students. J Sport Exerc Psychol. 2007 Apr;29(2):239-52. doi: 10.1123/jsep.29.2.239.
PubMed 17568069Kao SC, Westfall DR, Parks AC, Pontifex MB, Hillman CH. Muscular and Aerobic Fitness, Working Memory, and Academic Achievement in Children. Med Sci Sports Exerc. 2017 Mar;49(3):500-508. doi: 10.1249/MSS.0000000000001132.
PubMed 27776002Ludyga S, Gerber M, Kamijo K. Exercise types and working memory components during development. Trends Cogn Sci. 2022 Mar;26(3):191-203. doi: 10.1016/j.tics.2021.12.004. Epub 2022 Jan 11.
PubMed 35031211Haga M. The relationship between physical fitness and motor competence in children. Child Care Health Dev. 2008 May;34(3):329-34. doi: 10.1111/j.1365-2214.2008.00814.x.
PubMed 18410639Hillman CH, Pontifex MB, Raine LB, Castelli DM, Hall EE, Kramer AF. The effect of acute treadmill walking on cognitive control and academic achievement in preadolescent children. Neuroscience. 2009 Mar 31;159(3):1044-54. doi: 10.1016/j.neuroscience.2009.01.057. Epub 2009 Feb 3.
PubMed 19356688Ullman MT, Pierpont EI. Specific language impairment is not specific to language: the procedural deficit hypothesis. Cortex. 2005 Jun;41(3):399-433. doi: 10.1016/s0010-9452(08)70276-4.
PubMed 15871604Alt M, Gray S, Hogan TP, Schlesinger N, Cowan N. Spoken Word Learning Differences Among Children With Dyslexia, Concomitant Dyslexia and Developmental Language Disorder, and Typical Development. Lang Speech Hear Serv Sch. 2019 Oct 10;50(4):540-561. doi: 10.1044/2019_LSHSS-VOIA-18-0138. Epub 2019 Oct 10.
PubMed 31600465Braaksma P, Stuive I, Garst RME, Wesselink CF, van der Sluis CK, Dekker R, Schoemaker MM. Characteristics of physical activity interventions and effects on cardiorespiratory fitness in children aged 6-12 years-A systematic review. J Sci Med Sport. 2018 Mar;21(3):296-306. doi: 10.1016/j.jsams.2017.07.015. Epub 2017 Jul 20.
PubMed 28899655Pruitt M, Morini G. Examining the Role of Physical Activity on Word Learning in School-Aged Children. J Speech Lang Hear Res. 2021 May 11;64(5):1712-1725. doi: 10.1044/2021_JSLHR-20-00359. Epub 2021 Apr 28.
PubMed 33909448Hall, L., Hume, C., & Tazzyman, S. (2016, June). Five degrees of happiness: Effective smiley face likert scales for evaluating with children. In Proceedings of the the 15th international conference on interaction design and children (pp. 311-321).
Leger LA, Lambert J. A maximal multistage 20-m shuttle run test to predict VO2 max. Eur J Appl Physiol Occup Physiol. 1982;49(1):1-12. doi: 10.1007/BF00428958.
PubMed 7201922
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as Treatment in Children With Communication Impairments
- ClinicalTrials.gov ID
- NCT06340893
- Acronym / sponsor ID
- 76117
- Conditions
- Developmental Language Disorder
- Keywords
- developmental language disorder, exercise, learning, word learning, fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 2 Apr 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThis group will receive treatment 3x/week for 6 weeks |
| Restful Play | Sham comparator | Behavioral: Restful PlayThis group will receive treatment 3x/week for 6 weeks. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with a diagnosis of developmental language disorder (DLD) or typically developing controls will be included.
- (1) between 5 and 9 years old at enrollment
- (2) from homes where the primary language spoken is English
- (3) normal hearing based on parent report and audiometric screening
- (4) typical nonverbal cognition as determined by a T-score within 1.5 standard deviations of the mean on nonverbal subtests of the Reynolds Intellectual Assessment Scales
Key exclusion criteria (4 listed)
- (1) diagnosis of disorder that significantly affects social interactions (e.g., autism), as per referral diagnosis or which is identified during initial screening or assessment phase
- (2) vision impairments that prevent participation in our experimental protocol
- (3) inability for any reason to participate in assessment and/or treatment protocols
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 |
|---|---|---|
| ExerciseParticipants will participate in cardiovascular, agility, balance, strength and coordination training. | Behavioural | Exercise |
| Restful PlayThis group will engage in restful play activities such as coloring and playing with legos. | Behavioural | Restful Play |
Primary outcome
Changes to cognitive-linguistic performance: Word learning accuracy (% correct)
Time frame: Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)
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.
Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds)
Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
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.
3 secondary outcomes
Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)
Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Motor Performance (scaled scores)
Time frame: pre-treatment, immediately post-treatment
Enjoyment of Intervention
Time frame: Immediately post each treatment session (n = 18) up to 6 weeks.
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 21 May 2025.
- Background: PubMed 36041512Iuzzini-Seigel J, Moorer L, Tamplain P. An Investigation of Developmental Coordination Disorder Characteristics in Children With Childhood Apraxia of Speech. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):1006-1021. doi: 10.1044/2022_LSHSS-21-00163. Epub 2022 Aug 30.
- Background: PubMed 31479382Iuzzini-Seigel J. Motor Performance in Children With Childhood Apraxia of Speech and Speech Sound Disorders. J Speech Lang Hear Res. 2019 Sep 20;62(9):3220-3233. doi: 10.1044/2019_JSLHR-S-18-0380. Epub 2019 Sep 3.
- Background: PubMed 33784194Iuzzini-Seigel J. Procedural Learning, Grammar, and Motor Skills in Children With Childhood Apraxia of Speech, Speech Sound Disorder, and Typically Developing Speech. J Speech Lang Hear Res. 2021 Apr 14;64(4):1081-1103. doi: 10.1044/2020_JSLHR-20-00581. Epub 2021 Mar 30.
- Background: PubMed 20360463Zelaznik HN, Goffman L. Generalized motor abilities and timing behavior in children with specific language impairment. J Speech Lang Hear Res. 2010 Apr;53(2):383-93. doi: 10.1044/1092-4388(2009/08-0204).
- Background: PubMed 17568069Castelli DM, Hillman CH, Buck SM, Erwin HE. Physical fitness and academic achievement in third- and fifth-grade students. J Sport Exerc Psychol. 2007 Apr;29(2):239-52. doi: 10.1123/jsep.29.2.239.
- Background: PubMed 27776002Kao SC, Westfall DR, Parks AC, Pontifex MB, Hillman CH. Muscular and Aerobic Fitness, Working Memory, and Academic Achievement in Children. Med Sci Sports Exerc. 2017 Mar;49(3):500-508. doi: 10.1249/MSS.0000000000001132.
- Background: PubMed 35031211Ludyga S, Gerber M, Kamijo K. Exercise types and working memory components during development. Trends Cogn Sci. 2022 Mar;26(3):191-203. doi: 10.1016/j.tics.2021.12.004. Epub 2022 Jan 11.
- Background: PubMed 18410639Haga M. The relationship between physical fitness and motor competence in children. Child Care Health Dev. 2008 May;34(3):329-34. doi: 10.1111/j.1365-2214.2008.00814.x.
- Background: PubMed 19356688Hillman CH, Pontifex MB, Raine LB, Castelli DM, Hall EE, Kramer AF. The effect of acute treadmill walking on cognitive control and academic achievement in preadolescent children. Neuroscience. 2009 Mar 31;159(3):1044-54. doi: 10.1016/j.neuroscience.2009.01.057. Epub 2009 Feb 3.
- Background: PubMed 15871604Ullman MT, Pierpont EI. Specific language impairment is not specific to language: the procedural deficit hypothesis. Cortex. 2005 Jun;41(3):399-433. doi: 10.1016/s0010-9452(08)70276-4.
- Background: PubMed 31600465Alt M, Gray S, Hogan TP, Schlesinger N, Cowan N. Spoken Word Learning Differences Among Children With Dyslexia, Concomitant Dyslexia and Developmental Language Disorder, and Typical Development. Lang Speech Hear Serv Sch. 2019 Oct 10;50(4):540-561. doi: 10.1044/2019_LSHSS-VOIA-18-0138. Epub 2019 Oct 10.
- Background: PubMed 28899655Braaksma P, Stuive I, Garst RME, Wesselink CF, van der Sluis CK, Dekker R, Schoemaker MM. Characteristics of physical activity interventions and effects on cardiorespiratory fitness in children aged 6-12 years-A systematic review. J Sci Med Sport. 2018 Mar;21(3):296-306. doi: 10.1016/j.jsams.2017.07.015. Epub 2017 Jul 20.
- Individual participant dataSharing planned: Yes. Deidentified individual level data will be shared
Related trials for Developmental Language Disorder
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Not yet recruiting
Learning in Children With Developmental Language Disorder
Developmental Language Disorder
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Recruiting
The Impact of Music Medicine on Preterm Brain Development and Behavior
Infant Development, Language Development
Recruiting
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
Developmental Delays
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.
Danielle Rice contact
Jenya Iuzzini-Seigel, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Restful Play in people with Developmental Language Disorder, run by Marquette University 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 6 inclusion and 4 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 21 May 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. Some participants in this study may receive a placebo. 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 Jenya Iuzzini-Seigel, PhD (414-288-1529, jenya.iuzzini-seigel@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to cognitive-linguistic performance: Word learning accuracy (% correct) (time frame: Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340893, which also lists 17 linked publications.
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 21 May 2025.