Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340893
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-08
Brief Title:
Exercise Training in Children With Communication Impairments
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
Exercise as Treatment in Children With Communication Impairments
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial study has two goals The first goal is to establish fitness levels participation in physical activities and finegross motor abilities for children with development language disorder DLD DLD occurs in 113 children and children with DLD often have poorer finegross 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 finegross motor abilities more than participating in restful play activities
All children DLD and typically developing will undergo communication finegross 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 3xweek 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
All children DLD and typically developing will undergo communication finegross 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 3xweek 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 finegross 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 andor receptive language in 113 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 0Early 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 3xweek of exercise training ie activities to train cardiovascular fitness agility balance strength endurance or to a restful play condition eg 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
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 0Early 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 3xweek of exercise training ie activities to train cardiovascular fitness agility balance strength endurance or to a restful play condition eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None