Typical DevelopmentLittle-MoversNCT07091474
Promoting Motor Development in Infants and Toddlers Through Education and Early Detection
An observational study of Typical Development, run by University of Castilla-La Mancha.
Trial summary
The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays. Read more about this study
- Who is it for?
- Ages 0 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Typical Development
- What is being tested?
- Educational Workshops for Parents and Early Educators and Motor Development Assessment in Children 0-36 Months
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Observational
- 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 0 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population includes children aged 0 to 36 months with typical motor development who are enrolled in a participating kindergarten or early childhood education center. It also includes their primary caregivers (parents or legal guardians) and early childhood educators involved in the structured educational workshops.
Who may be able to join
- Legal guardians or primary caregivers of children aged 0 to 36 months enrolled in the participating daycare center. Early childhood educators working with children aged 0 to 36 months in the same center.
- Infants aged 0 to 12 months enrolled in the participating daycare center. Infants must not have a diagnosed neuromotor or neurological condition at the time of enrollment. Written informed consent must be obtained from a parent or legal guardian.
Who cannot join
- Children with diagnosed neurological or genetic conditions affecting motor development. Families or educators who decline participation or do not provide informed consent. Children or families not enrolled in the participating daycare center.
About this study
Official title: Little Movers: Promoting Motor Development in Early Childhood Through Educational and Therapeutic Interventions
The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays.
The primary prevention component includes structured educational workshops designed for three age groups: 0-12 months, 13-24 months, and 25-36 months. These workshops focus on typical motor milestones, the importance of active play, early stimulation strategies, and how to recognize early warning signs of motor development delays. Participation impact will be measured using pre- and post-workshop surveys and semi-structured interviews with parents, caregivers, and educators.
The secondary and tertiary prevention component consists of a longitudinal observational study that follows infants aged 0 to 12 months. Motor development will be assessed using validated tools, including the Standardized Infant Hand Assessment (s-HAI), the Hammersmith Infant Neurological Examination (HINE), the Infant Motor Profile (IMP), and the Ages and Stages Questionnaire (ASQ-3). Infants with typical development will be reassessed annually, while those at risk or showing signs of motor delay will be monitored monthly. The goal is to detect motor delays as early as possible to allow timely referral and intervention.
- Conditions
- Typical Development
- Being tested
- Educational Workshops for Parents and Early Educators, Motor Development Assessment in Children 0-36 Months
- Keywords
- motor development, education, prevention, family, early age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Workshops for Parents and Early EducatorsBehavioural
A structured series of age-specific educational workshops designed for parents, caregivers, and early childhood educators of children aged 0-36 months. The workshops are organized into three cohorts (0-12 months, 13-24 months, 25-36 months) and focus on typical motor milestones, active play, early stimulation strategies, and recognition of early warning signs of motor delays. Sessions include interactive activities, discussions, and distribution of educational resources. Pre- and post-workshop surveys and semi-structured interviews are conducted to evaluate changes in knowledge and attitudes.
Motor Development Assessment in Children 0-36 MonthsOther
Comprehensive motor development assessments performed on infants aged 0-36 months using validated tools (Standardized Infant Hand Assessment [s-HAI], Hammersmith Infant Neurological Examination [HINE], Infant Motor Profile [IMP], and Ages and Stages Questionnaire [ASQ-3]). These evaluations aim to collect normative data on typical early motor development and to identify early signs of motor delays or neurological conditions, enabling timely referral and intervention. Assessments are conducted annually for typically developing infants and monthly for those identified as at risk.
| Study group | Role | What they receive |
|---|---|---|
| Families and Early Childhood Educators | This cohort includes families of children aged 0-36 months and early childhood educators enrolled in structured educational workshops. The intervention consists of age-specific sessions tailored to three cohorts (0-12 months, 13-24 months, 25-36 months). Sessions provide education on motor milestones, the role of play, early stimulation techniques, and early warning signs of motor delays. Parents, caregivers, and educators participate in interactive discussions, practical activities, and resource sharing to enhance knowledge and support early motor development. Receives: Behavioral: Educational Workshops for Parents and Early Educators | |
| Infants (0-36 months) | This cohort includes infants aged 0-36 months who will undergo motor development assessments using validated tools, including the Standardized Infant Hand Assessment (s-HAI), Ages and Stages Questionnaire (ASQ-3), Hammersmith Infant Neurological Examination (HINE), and Infant Motor Profile (IMP). Assessments are scheduled annually for typically developing infants and monthly for those at risk or showing early signs of motor delays. Receives: Other: Motor Development Assessment in Children 0-36 Months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver and educator knowledge and attitudes about motor development, as assessed with a 5-point Likert-scale questionnaire
Knowledge and attitudes toward early motor development will be evaluated using a structured questionnaire administered immediately before and after workshop sessions. The questionnaire includes 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Total scores are calculated as the average of all items. Higher scores represent greater knowledge and more positive attitudes toward the importance of early motor milestones and play-based stimulation.
Measured: Immediately before and immediately after each workshop session (same day)
Neurological function in infants assessed by the Hammersmith Infant Neurological Examination (HINE)
The Hammersmith Infant Neurological Examination (HINE) is a standardized clinical tool used to evaluate neurological function in infants aged 2 to 24 months. It includes domains such as cranial nerve function, posture, tone, and reflexes. The global score ranges from 0 to 78 points; higher scores indicate more typical neurological development. Scores below 40 in high-risk infants are associated with an increased probability of developing cerebral palsy.
Measured: Monthly assessments from 2 to 24 months of age.
Motor behavior in infants assessed by the Infant Motor Profile (IMP)
The Infant Motor Profile (IMP) is a standardized clinical assessment that evaluates the quality and variability of motor behavior in infants aged 3 to 18 months. The IMP provides scores across several domains (variation, adaptability, symmetry, fluency, and performance), with total scores calculated as a percentage (0-100%). Higher scores indicate more optimal and typical motor development. The assessment is designed to be repeated over time to monitor change in motor patterns, with results summarized as mean or change in percentage scores per assessment period.
Measured: Monthly assessments from 3 to 18 months of age
Secondary outcomes (2)
Unimanual hand function assessed by the Standardized Infant Hand Assessment (s-HAI)
The s-HAI is a standardized tool to assess hand function in infants at risk for unilateral motor impairments. It evaluates spontaneous use of each hand during structured play activities. The total score ranges from 0 to 100 points. Higher scores reflect better unimanual hand performance. It is validated for use with infants between 3 and 12 months of age, particularly those with early signs of asymmetric movement or neurological risk factors.
Measured: Monthly from 3 to 12 months of age
Developmental progress assessed by Ages and Stages Questionnaire, Third Edition (ASQ-3)
The Ages and Stages Questionnaire, Third Edition (ASQ-3) is a parent-completed screening tool used to assess development in five domains: communication, gross motor, fine motor, problem solving, and personal-social skills, for children between 1 month and 5½ years. Each domain is scored separately, and results are compared to standardized age norms. Lower scores in any domain may indicate a risk of developmental delay. Scores are summarized for each domain and interpreted using established cut-off points.
Measured: Monthly from birth to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical DevelopmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091474
- Sponsor's protocol ID
- Little movers
- Acronym
- Little-Movers
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Little Movers: Promoting Motor Development in Early Childhood Through Educational and Therapeutic Interventions
- ClinicalTrials.gov ID
- NCT07091474
- Acronym / sponsor ID
- Little-Movers / Little movers
- Conditions
- Typical Development
- Keywords
- motor development, education, prevention, family, early age
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays.
The primary prevention component includes structured educational workshops designed for three age groups: 0-12 months, 13-24 months, and 25-36 months. These workshops focus on typical motor milestones, the importance of active play, early stimulation strategies, and how to recognize early warning signs of motor development delays. Participation impact will be measured using pre- and post-workshop surveys and semi-structured interviews with parents, caregivers, and educators.
The secondary and tertiary prevention component consists of a longitudinal observational study that follows infants aged 0 to 12 months. Motor development will be assessed using validated tools, including the Standardized Infant Hand Assessment (s-HAI), the Hammersmith Infant Neurological Examination (HINE), the Infant Motor Profile (IMP), and the Ages and Stages Questionnaire (ASQ-3). Infants with typical development will be reassessed annually, while those at risk or showing signs of motor delay will be monitored monthly. The goal is to detect motor delays as early as possible to allow timely referral and intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Families and Early Childhood Educators | – | Behavioral: Educational Workshops for Parents and Early EducatorsThis cohort includes families of children aged 0-36 months and early childhood educators enrolled in structured educational workshops. The intervention consists of age-specific sessions tailored to three cohorts (0-12 months, 13-24 months, 25-36 months). Sessions provide education on motor milestones, the role of play, early stimulation techniques, and early warning signs of motor delays. Parents, caregivers, and educators participate in interactive discussions, practical activities, and resource sharing to enhance knowledge and support early motor development. |
| Infants (0-36 months) | – | Other: Motor Development Assessment in Children 0-36 MonthsThis cohort includes infants aged 0-36 months who will undergo motor development assessments using validated tools, including the Standardized Infant Hand Assessment (s-HAI), Ages and Stages Questionnaire (ASQ-3), Hammersmith Infant Neurological Examination (HINE), and Infant Motor Profile (IMP). Assessments are scheduled annually for typically developing infants and monthly for those at risk or showing early signs of motor delays. |
Who may qualify
- Ages
- 0 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population includes children aged 0 to 36 months with typical motor development who are enrolled in a participating kindergarten or early childhood education center. It also includes their primary caregivers (parents or legal guardians) and early childhood educators involved in the structured educational workshops.
Key inclusion criteria (2 listed)
- Legal guardians or primary caregivers of children aged 0 to 36 months enrolled in the participating daycare center. Early childhood educators working with children aged 0 to 36 months in the same center.
- Infants aged 0 to 12 months enrolled in the participating daycare center. Infants must not have a diagnosed neuromotor or neurological condition at the time of enrollment. Written informed consent must be obtained from a parent or legal guardian.
Key exclusion criteria (1 listed)
- Children with diagnosed neurological or genetic conditions affecting motor development. Families or educators who decline participation or do not provide informed consent. Children or families not enrolled in the participating daycare center.
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 |
|---|---|---|
| Educational Workshops for Parents and Early EducatorsA structured series of age-specific educational workshops designed for parents, caregivers, and early childhood educators of children aged 0-36 months. The workshops are organized into three cohorts (0-12 months, 13-24 months, 25-36 months) and focus on typical motor milestones, active play, early stimulation strategies, and recognition of early warning signs of motor delays. Sessions include interactive activities, discussions, and distribution of educational resources. Pre- and post-workshop surveys and semi-structured interviews are conducted to evaluate changes in knowledge and attitudes. | Behavioural | Families and Early Childhood Educators |
| Motor Development Assessment in Children 0-36 MonthsComprehensive motor development assessments performed on infants aged 0-36 months using validated tools (Standardized Infant Hand Assessment [s-HAI], Hammersmith Infant Neurological Examination [HINE], Infant Motor Profile [IMP], and Ages and Stages Questionnaire [ASQ-3]). These evaluations aim to collect normative data on typical early motor development and to identify early signs of motor delays or neurological conditions, enabling timely referral and intervention. Assessments are conducted annually for typically developing infants and monthly for those identified as at risk. | Other | Infants (0-36 months) |
Primary outcome
Change in caregiver and educator knowledge and attitudes about motor development, as assessed with a 5-point Likert-scale questionnaire
Time frame: Immediately before and immediately after each workshop session (same day)
Knowledge and attitudes toward early motor development will be evaluated using a structured questionnaire administered immediately before and after workshop sessions. The questionnaire includes 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Total scores are calculated as the average of all items. Higher scores represent greater knowledge and more positive attitudes toward the importance of early motor milestones and play-based stimulation.
Neurological function in infants assessed by the Hammersmith Infant Neurological Examination (HINE)
Time frame: Monthly assessments from 2 to 24 months of age.
The Hammersmith Infant Neurological Examination (HINE) is a standardized clinical tool used to evaluate neurological function in infants aged 2 to 24 months. It includes domains such as cranial nerve function, posture, tone, and reflexes. The global score ranges from 0 to 78 points; higher scores indicate more typical neurological development. Scores below 40 in high-risk infants are associated with an increased probability of developing cerebral palsy.
Motor behavior in infants assessed by the Infant Motor Profile (IMP)
Time frame: Monthly assessments from 3 to 18 months of age
The Infant Motor Profile (IMP) is a standardized clinical assessment that evaluates the quality and variability of motor behavior in infants aged 3 to 18 months. The IMP provides scores across several domains (variation, adaptability, symmetry, fluency, and performance), with total scores calculated as a percentage (0-100%). Higher scores indicate more optimal and typical motor development. The assessment is designed to be repeated over time to monitor change in motor patterns, with results summarized as mean or change in percentage scores per assessment period.
2 secondary outcomes
Unimanual hand function assessed by the Standardized Infant Hand Assessment (s-HAI)
Time frame: Monthly from 3 to 12 months of age
Developmental progress assessed by Ages and Stages Questionnaire, Third Edition (ASQ-3)
Time frame: Monthly from birth to 12 months of age
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 29 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Typical Development, run by University of Castilla-La Mancha.
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 1 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
Change in caregiver and educator knowledge and attitudes about motor development, as assessed with a 5-point Likert-scale questionnaire (time frame: Immediately before and immediately after each workshop session (same day)). The study lists 3 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 29 Jul 2025.