Down SyndromeNCT05144373
Role of Early Motor Experience in Infants With Down Syndrome
A study testing Gross motor intervention, gross and fine motor intervention in people with Down Syndrome, run by Georgia State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 36 months
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Gross motor intervention, gross and fine motor intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- An appropriate age range of 7-36 months
- A diagnosis of Down syndrome.
Who cannot join
- The presence of seizure disorders
- Non-correctable vision, hearing and heart problems
- Any other severe medical conditions that may prevent the infant from participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Down syndrome (DS) is the most common genetic condition and causes significant development delays and weaknesses in the motor, cognitive, and language domains. It is important to study these co-occurring developmental challenges and develop effective intervention strategies for positive learning outcomes in multiple domains simultaneously. It was found that motor development is closely associated with cognitive and language development in typically developing infants and advances in motor development have developmental cascade effects on other domains. However, this interrelation has not been studied in infants with DS. Our prior work has shown that gross motor experience through body-weight-supported treadmill stepping leads to an earlier onset of walking and improves subsequent locomotor ability in infants with DS. However, we do not yet know the extent to which this motor experience advances cognitive and language development in infants with DS. Research also suggests that grasping, a major fine motor skill emerging in infancy, provides the needed scaffolding for subsequent gesture and speech production. However, research on grasping and its potential effects on other domains in infants with DS remains scarce. The objectives of this proposal are to understand: the role of (a) specific gross motor experience and (b) specific fine motor experience on the motor, cognitive and language development of infants with DS. Our central hypothesis is that motor (both gross and fine) experience will help advance cognitive and language development in infants with DS. We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. Aim 1: Determine the effects of gross motor experience on cognitive and language development in infants with DS, comparing the GM and control groups. Only the GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age (T1) until onset of walking. We hypothesize that the GM group will show higher Bayley scores and better gesture and word production at termination of the GM intervention (T3) and five months thereafter (T4) than the control group. Aim 2: Determine the effects of fine motor experience on cognitive and language development in infants with DS who receive the GM intervention, particularly in gesture and word production, comparing the GM and GM+FM groups. Only the GM+FM group will receive fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. We hypothesize that the GM+FM group will show further improvements in motor, cognitive and language domains, particularly in gesture and word production, than the GM group at termination of the FM intervention (T2) and again at T3 and T4. Our study will gain an in-depth understanding of the cascading effects of motor experience on cognitive and language development and lay the groundwork for future clinical trials in infants with DS.
- Conditions
- Down Syndrome
- Being tested
- Gross motor intervention, gross and fine motor intervention
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross motor intervention, gross and fine motor interventionBehavioural
For gross motor intervention, participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset.
For gross and fine motor intervention, participants will receive the same treadmill intervention as illustrated above. In addition, participants will receive a fine motor intervention with practice of reaching and grasping using "sticky mittens" from about 10 months of age for five months.
| Study group | Role | What they receive |
|---|---|---|
| Gross motor intervention | Experimental | Participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset. Receives: Behavioral: Gross motor intervention, gross and fine motor intervention |
| Gross and fine motor intervention | Experimental | 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. Receives: Behavioral: Gross motor intervention, gross and fine motor intervention |
| Control | No intervention | Participants will not receive specific intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Measured: 10 months for GM and GM+FM groups
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Measured: 15 months for GM and GM+FM groups
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Measured: 20 months for all three groups
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Measured: 25 months for all three groups
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Measured: 10 months for GM and GM+FM groups
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Measured: 15 months for GM and GM+FM groups
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Measured: 20 months for all three groups
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Measured: 25 months for all three groups
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Measured: 10 months for GM and GM+FM groups
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Measured: 15 months for GM and GM+FM groups
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Measured: 20 months for all three groups
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Measured: 25 months for all three groups
Secondary outcomes (4)
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Measured: 10 months for GM and GM+FM groups
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Measured: 15 months for GM and GM+FM groups
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Measured: 20 months for all three groups
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Measured: 25 months for all three groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Jan 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. The GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age until walking onset. The GM+FM group will receive both treadmill intervention from 10 months of age until walking onset as well as fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. The control group will not receive an intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jianhua Wu, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144373
- Sponsor's protocol ID
- H21604
- Other IDs
- 1R21HD105879-01, 352307
- Status last verified
- Dec 2025
- First submitted
- 5 Oct 2021
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will upload the data to the National Institutes of Health INCLUDE data coordination center (DCC). We will share the de-identified data including demographics, diagnosis, and motor, cognitive, and language developmental profile. We will also share the video data including the captured motion data and the footage of parent-child interaction.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Early Motor Experience in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT05144373
- Acronym / sponsor ID
- H21604
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 3 Dec 2021 (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.
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.
Detailed description
Down syndrome (DS) is the most common genetic condition and causes significant development delays and weaknesses in the motor, cognitive, and language domains. It is important to study these co-occurring developmental challenges and develop effective intervention strategies for positive learning outcomes in multiple domains simultaneously. It was found that motor development is closely associated with cognitive and language development in typically developing infants and advances in motor development have developmental cascade effects on other domains. However, this interrelation has not been studied in infants with DS. Our prior work has shown that gross motor experience through body-weight-supported treadmill stepping leads to an earlier onset of walking and improves subsequent locomotor ability in infants with DS. However, we do not yet know the extent to which this motor experience advances cognitive and language development in infants with DS. Research also suggests that grasping, a major fine motor skill emerging in infancy, provides the needed scaffolding for subsequent gesture and speech production. However, research on grasping and its potential effects on other domains in infants with DS remains scarce. The objectives of this proposal are to understand: the role of (a) specific gross motor experience and (b) specific fine motor experience on the motor, cognitive and language development of infants with DS. Our central hypothesis is that motor (both gross and fine) experience will help advance cognitive and language development in infants with DS. We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. Aim 1: Determine the effects of gross motor experience on cognitive and language development in infants with DS, comparing the GM and control groups. Only the GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age (T1) until onset of walking. We hypothesize that the GM group will show higher Bayley scores and better gesture and word production at termination of the GM intervention (T3) and five months thereafter (T4) than the control group. Aim 2: Determine the effects of fine motor experience on cognitive and language development in infants with DS who receive the GM intervention, particularly in gesture and word production, comparing the GM and GM+FM groups. Only the GM+FM group will receive fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. We hypothesize that the GM+FM group will show further improvements in motor, cognitive and language domains, particularly in gesture and word production, than the GM group at termination of the FM intervention (T2) and again at T3 and T4. Our study will gain an in-depth understanding of the cascading effects of motor experience on cognitive and language development and lay the groundwork for future clinical trials in infants with DS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. The GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age until walking onset. The GM+FM group will receive both treadmill intervention from 10 months of age until walking onset as well as fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. The control group will not receive an intervention.
| Arm | Type | Receives |
|---|---|---|
| Gross motor intervention | Experimental | Behavioral: Gross motor intervention, gross and fine motor interventionParticipants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset. |
| Gross and fine motor intervention | Experimental | Behavioral: Gross motor intervention, gross and fine motor interventionBesides 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. |
| Control | No intervention | –Participants will not receive specific intervention. |
Who may qualify
- Ages
- 7 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- An appropriate age range of 7-36 months
- A diagnosis of Down syndrome.
Key exclusion criteria (3 listed)
- The presence of seizure disorders
- Non-correctable vision, hearing and heart problems
- Any other severe medical conditions that may prevent the infant from participating in this study
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 |
|---|---|---|
| Gross motor intervention, gross and fine motor interventionFor gross motor intervention, participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset. For gross and fine motor intervention, participants will receive the same treadmill intervention as illustrated above. In addition, participants will receive a fine motor intervention with practice of reaching and grasping using "sticky mittens" from about 10 months of age for five months. | Behavioural | Gross and fine motor intervention, Gross motor intervention |
Primary outcome
Bayley cognitive scores
Time frame: 10 months for GM and GM+FM groups
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
Time frame: 15 months for GM and GM+FM groups
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
Time frame: 20 months for all three groups
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
Time frame: 25 months for all three groups
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley language scores
Time frame: 10 months for GM and GM+FM groups
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
Time frame: 15 months for GM and GM+FM groups
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
Time frame: 20 months for all three groups
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
Time frame: 25 months for all three groups
The Bayley Scale of Infant and Toddler Development language composite scores
Gesture production
Time frame: 10 months for GM and GM+FM groups
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
Time frame: 15 months for GM and GM+FM groups
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
Time frame: 20 months for all three groups
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
Time frame: 25 months for all three groups
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
4 secondary outcomes
Bayley motor scores
Time frame: 10 months for GM and GM+FM groups
Bayley motor scores
Time frame: 15 months for GM and GM+FM groups
Bayley motor scores
Time frame: 20 months for all three groups
Bayley motor scores
Time frame: 25 months for all three groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. We will upload the data to the National Institutes of Health INCLUDE data coordination center (DCC). We will share the de-identified data including demographics, diagnosis, and motor, cognitive, and language developmental profile. We will also share the video data including the captured motion data and the footage of parent-child interaction.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gross motor intervention, gross and fine motor intervention in people with Down Syndrome, run by Georgia State 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Dec 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley cognitive scores (time frame: 10 months for GM and GM+FM groups). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.