Early Motor Experience for Down Syndrome
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Georgia State University
Disqualifiers: Seizure disorders, Vision, Hearing, Heart, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Infants with Down syndrome show significant delays and weaknesses in motor, cognitive, and language development compared to typically developing infants. This project aims to examine the developmental cascade effects of specific gross and fine motor experience on motor, cognitive and language development in infants with Down syndrome. We propose that both gross and fine motor experience will facilitate cognitive and language development in infants with Down syndrome, and particularly, fine motor experience will help advance gesture and early words production.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment for early motor experience in children with Down syndrome?
Research shows that early physical therapy can help improve motor development in children with Down syndrome, especially when started before the age of one. Additionally, physical therapy has been found to benefit people with intellectual disabilities by improving their gross motor skills.
12345Is early motor experience therapy safe for humans?
The research does not provide specific safety data for early motor experience therapy, but physical therapy interventions for improving motor skills are generally considered safe for people with intellectual disabilities and children with neurodevelopmental disorders.
24567How does the Early Motor Experience treatment for Down Syndrome differ from other treatments?
The Early Motor Experience treatment for Down Syndrome is unique because it focuses on both gross and fine motor skills through physical therapy, starting at a very young age, which can help improve motor development and potentially lead to earlier independent walking. This approach is different from other treatments as it emphasizes early intervention and task-specific training, such as treadmill interventions, to address motor delays.
238910Eligibility Criteria
This trial is for infants aged 7-24 months who have been diagnosed with Down syndrome. It's not suitable for those with seizure disorders, uncorrectable vision or hearing issues, heart problems, or any severe medical conditions that would limit their participation.Inclusion Criteria
You have Down syndrome.
My child is between 7 and 24 months old.
Exclusion Criteria
I have a seizure disorder.
I have vision, hearing, or heart issues that cannot be fixed.
My infant has no severe medical conditions that would prevent participation.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Gross Motor Intervention
Participants receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset
Approximately 5 months
Home-based intervention
Gross and Fine Motor Intervention
Participants receive additional fine motor intervention using 'sticky mittens' from about 10 months of age for five months
5 months
Home-based intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 months
Participant Groups
The study is testing the impact of specific motor experiences on development in infants with Down syndrome. It will explore how gross motor (like crawling) and fine motor (like grasping) interventions can influence cognitive and language skills.
3Treatment groups
Experimental Treatment
Active Control
Group I: Gross motor interventionExperimental Treatment1 Intervention
Participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset.
Group II: Gross and fine motor interventionExperimental Treatment1 Intervention
Besides the body-weight supported treadmill intervention as illustrated above, participants will receive additional fine motor intervention using "sticky mittens" from about 10 months of age for five months.
Group III: ControlActive Control1 Intervention
Participants will not receive specific intervention.
Gross and fine motor intervention is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Physical Therapy for:
- Motor Development Delay
- Cognitive Development Delay
- Language Development Delay
🇪🇺 Approved in European Union as Motor Intervention for:
- Down Syndrome
- Motor Skill Development
- Cognitive and Language Development
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Biomechanics labAtlanta, GA
Loading ...
Who Is Running the Clinical Trial?
Georgia State UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Motor-language links in children with Down syndrome: a scoping review to revisit the literature with a developmental cascades lens. [2023]Label="Background" NlmCategory="UNASSIGNED">Children with Down syndrome (DS) typically have motor and language needs. Improving function is a shared goal for the rehabilitation therapy team, however physical therapy, occupational therapy, and speech-language pathology professionals treat patients differently. This difference in care may mask developmental cascades whereby changes in one domain (e.g., motor) can have seemingly unexpected effects on another domain (e.g., language).
A schedule of gross motor development for children with Down syndrome. [2020]Gross motor milestones for children who develop typically have been well established; however, norms for children with Down syndrome (DS) are uncertain. Without a developmental schedule for the gross motor development of children with DS, medical professionals are limited in their ability to identify if the development of a particular child with DS is delayed in comparison with his or her peers (i.e. other children with DS), assess when intervention is needed and answer the questions of parents regarding when their child can be expected to achieve developmental milestones. The objectives of this study are to: (1) provide health care professionals and early intervention providers with longitudinal data on the gross motor development of children with DS gathered prospectively; (2) contribute to the development of a definitive schedule of gross motor development for children with DS; (3) enable the identification of gross motor development that is delayed in comparison with other children with DS; and (4) help medical professionals address the questions of concerned parents who are anxious to know when their child will achieve gross motor skills such as sitting, crawling or walking.
Effects of early physical therapy on motor development in children with Down syndrome. [2022]The objective of the study was to compare the motor development of children with Down syndrome (DS) who received physical therapy (PT) and did not receive PT, and to show the effect of PT programs started before the age of one on movement development.
Physical therapy interventions for gross motor skills in people with an intellectual disability aged 6 years and over: a systematic review. [2018]The systematic review was undertaken to investigate the effectiveness of physical therapy interventions for improving gross motor skills (GMSs) in people with an intellectual disability aged 6 years and older. There is a lack of physical therapy research for GMSs in this population, and no prior systematic review. People with an intellectual disability may require specific teaching approaches within therapy interventions to accommodate their cognitive and learning needs. People with an intellectual disability who suffer from GMS deficits can benefit from physical therapy to help improve their GMSs.
Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. [2022]Gross motor skills are fundamental to childhood development. The effectiveness of current physical therapy options for children with mild to moderate gross motor disorders is unknown. The aim of this study was to systematically review the literature to investigate the effectiveness of conservative interventions to improve gross motor performance in children with a range of neurodevelopmental disorders.
Basic gross motor assessment. Tool for use with children having minor motor dysfunction. [2019]Children with minor motor problems are often referred for evaluation of these problems to physical therapists who work in educational environments. Measures that therapists use to assess seriously disabled children are often inappropriate for these children. The Basic Gross Motor Assessment was developed after analyzing research on minor motor dysfunction. Standard procedures were outlined and a sample of 1,260 randomly selected children aged 5 years 6 months to 12 years 5 months served for norming purposes. Validity and reliability studies were completed with an additional 285 subjects. The Basic Gross Motor Assessment is presented as a useful tool for evaluating minor motor problems in children and identifying those children who require further physical therapy assessment and perhaps direct treatment.
Validity of the Peabody Developmental Gross Motor Scale as an evaluative measure of infants receiving physical therapy. [2019]The purpose of this study was to examine the validity of the Peabody Developmental Gross Motor Scale (PDMS-GM) as an evaluative measure of infants receiving physical therapy.
Delays in Motor Development in Children with Down Syndrome. [2018]Children with Down syndrome (DS) present with delays in motor development. The reduced size of the cerebrum, brain maturation disorders, and pathophysiological processes lead to motor development delay. The aim of this study was to examine the gross motor function and estimate what motor abilities are significantly delayed in children with Down syndrome even if they attend physical therapy sessions. Another purpose of the study was to assess the functional balance.
Can early physical therapy positively affect the onset of independent walking in infants with Down syndrome? A retrospective cohort study. [2022]The development of both gross and fine motor skills in a child with Down syndrome is generally delayed. The most seriously affected stage is the achievement of independent walking ability, which influences the onset of all following motor and cognitive skills. The study objectives were: 1) to assess the time taken to achieve independent walking ability in a cohort of children with Down syndrome; 2) to examine differences in walking onset by patient characteristics; and 3) to verify the effect of early physical therapy (neurodevelopmental treatment based on Bobath Concept practiced within the first months of life) in the achievement of that skill.
Treadmill interventions with partial body weight support in children under six years of age at risk of neuromotor delay: a report of a Cochrane systematic review and meta-analysis. [2018]Delayed motor development may occur in children with Down syndrome, cerebral palsy or children born preterm, which in turn may limit the child's opportunities to explore the environment. Neurophysiologic and early intervention literature suggests that task-specific training facilitates motor development. Treadmill intervention is a good example of locomotor task-specific training.