Fine Motor SkillsNCT06619691
HOFOT Fine Motor Program
A study testing Fine motor skills in people with Fine Motor Skills, run by Mercy University at 1 site in United States.
Trial summary
The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Fine Motor Skills
- What is being tested?
- Fine motor skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Jun 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschooler aged 3-5 years old enrolled in local preschool
Who cannot join
- None other than denial of parent consent or lack of child assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy University
Dobbs Ferry, New York, 10950
Elizabeth Berliner, 914-674-7688, eberliner@mercy.edu
About this study
Official title: Hands on Fun Occupational Therapy Fine Motor Program
The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test.
Read the detailed description
The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (Peabody Developmental Motor Scale, 3rd edition) in pre- and post-test. The hypothesis is that a daily fine motor program will improve overall fine motor skills within 8 weeks.
- Conditions
- Fine Motor Skills
- Being tested
- Fine motor skills
- Keywords
- Preschool, fine motor program, fine motor skills, early childhood development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine motor skillsOther
Only intervention
| Study group | Role | What they receive |
|---|---|---|
| FIne Motor Program participants | Experimental | All enrolled participants will completed a fine motor intervention program over 8 weeks Receives: Other: Fine motor skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scale, 3rd Edition
Peabody Developmental Motor Scales, 3rd edition - Norm referenced and standardized assessment of fine motor skills for children ages birth-5.11
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine Motor SkillsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619691
- Sponsor's protocol ID
- 24-77
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hands on Fun Occupational Therapy Fine Motor Program
- ClinicalTrials.gov ID
- NCT06619691
- Acronym / sponsor ID
- 24-77
- Conditions
- Fine Motor Skills
- Keywords
- Preschool, fine motor program, fine motor skills, early childhood development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mercy UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Oct 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.
The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test.
Detailed description
The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (Peabody Developmental Motor Scale, 3rd edition) in pre- and post-test. The hypothesis is that a daily fine motor program will improve overall fine motor skills within 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIne Motor Program participants | Experimental | Other: Fine motor skillsAll enrolled participants will completed a fine motor intervention program over 8 weeks |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschooler aged 3-5 years old enrolled in local preschool
Key exclusion criteria (1 listed)
- None other than denial of parent consent or lack of child assent
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 |
|---|---|---|
| Fine motor skillsOnly intervention | Other | FIne Motor Program participants |
Primary outcome
Peabody Developmental Motor Scale, 3rd Edition
Time frame: 8 weeks
Peabody Developmental Motor Scales, 3rd edition - Norm referenced and standardized assessment of fine motor skills for children ages birth-5.11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine motor skills in people with Fine Motor Skills, run by Mercy 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 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Berliner, MS (914-674-7688, eberliner@mercy.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scale, 3rd Edition (time frame: 8 weeks). 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 3 Oct 2024.