Developmental DelayNCT05825248
Comparing Two Protocols to Improve Reflex Integration and Functional Performance
A study testing Fine and gross motor treatment only and Reflex integration + fine and gross motor treatment in people with Developmental Delay, run by Salus University at 1 site in United States.
Trial summary
The goal of this quantitative experimental study is to compare two occupational therapy interventions intended to improve functional skills. The main questions it aims to answer are: Question 1: Do preschool children who participate in occupational therapy intervention designed to promote integration of the TLR reflex… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Fine and gross motor treatment only and Reflex integration + fine and gross motor treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 15 Jun 2023
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 to <6 years old
- Attending preschool at Hopkins Preschool, Stevens Elementary Preschool, or Central Park Preschool within Aberdeen School District
- Receiving weekly occupational therapy services to address fine motor, gross motor, or sensory deficits
- Displays signs of retained tonic labyrinthine reflex (TLR) after a brief INNP TLR screening test (a score of 3, or 4 will be considered a retained TLR for the purpose of this study)
Who cannot join
- Students enrolled in an alternative enrollment format
- Students who are absent for a consecutive period of 5 or more school days
Trial locations and contacts
1 site in 1 country.
United States1 site
Aberdeen School District
Aberdeen, Washington, 98520
About this study
The goal of this quantitative experimental study is to compare two occupational therapy interventions intended to improve functional skills. The main questions it aims to answer are:
Question 1: Do preschool children who participate in occupational therapy intervention designed to promote integration of the TLR reflex in conjunction with fine and gross motor intervention demonstrate improved integration of the TLR reflex in clinical assessment, compared to children who participate in fine and gross motor intervention only for an equal amount of time?
Read more
Question 2: Do preschool children who participate in occupational therapy intervention designed to promote integration of the TLR reflex in conjunction with fine and gross motor intervention demonstrate improved integration of the TLR reflex in clinical assessment, compared to children who participate in fine and gross motor intervention only for an equal amount of time?
Participants will participate in either a therapy program consisting of either fine and gross motor treatment in conjunction with reflex integration treatment, or fine and gross motor treatment only.
If there is a comparison group: Researchers will compare the group recieving reflex integration in conjunction with fine and gross motor treatment and the fine and gross motor only group to see if one is more effective at integrating the reflex and/or improving functional skills.
Read the detailed description
Pre-intervention, INPP screening for TLR will be administered to determine eligibility for the study and baseline of reflex persistence. the Peabody Developmental Motor Scales 2nd Edition (PDMS2) stationary and visual motor integration sections will be administered to assess fine and gross motor skills. Stratified random sampling will be used to create two parallel groups. Both the INPP and PDMS2 will be administered and scored by a masked examiner who is licensed to practice occupational therapy.
For 6 weeks, one group will receive 20 minutes standard occupational therapy intervention while the second group will receive 10 minutes of standard occupational therapy intervention and 10 minutes of TLR integration protocol (Move Play Thrive Program). 20 minutes per week is standard treatment time for preschool occupational therapy sessions in Aberdeen School District. Intervention will be provided by the PI, Healey Miller.
Post-intervention, the Peabody Developmental Motor Scales 2nd Edition (PDMS2) stationary and visual motor integration sections will be re-administered to assess fine and gross motor skills and the INPP screening for TLR will be re-administered to assess for retained TLR reflex. Both the INPP and PDMS2 will be administered and scored by a masked examiner who is licensed to practice occupational therapy. Data will be reviewed to determine if the progress made between groups, in regard to motor skills and reflex integration, is statistically significant. Data will be reviewed to compare progress made in each group in fine/gross motor skills and reflex integration, and to determine if changes made are statistically significant.
- Conditions
- Developmental Delay
- Being tested
- Fine and gross motor treatment only, Reflex integration + fine and gross motor treatment
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine and gross motor treatment onlyOther
occupational therapy intervention involving general fine and gross motor activities
Reflex integration + fine and gross motor treatmentOther
Also called Move, Play, Thrive reflex integration exercises
occupational therapy intervention involving general fine and gross motor activities as well as targeted reflex integration exercises
| Study group | Role | What they receive |
|---|---|---|
| Reflex integration + fine and gross motor treatment | Experimental | For 20 minutes per week for 8 weeks, this group will recieve 10 minutes of fine and gross motor treatment and 10 minutes of reflex integration exercises from the Move Play Thrive program. Receives: Other: Reflex integration + fine and gross motor treatment |
| Fine and gross motor treatment only | Active comparator | For 20 minutes per week for 8 weeks, this group will recieve 20 minutes of standard occupational therapy treatment consisting of fine and gross motor intervention. Receives: Other: Fine and gross motor treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline functional skills at 8 weeks
functional skills as measured by the Peabody Developmental Motor Scales Stationary and Visual Motor Integration sections. This standardized test scoring can be converted into z-scores for data comparison.
Measured: week 0 and week 8
Change from baseline TLR inegration at 9 weeks
integration of the tonic labyrinthine reflex as measured by the INPP measure for retained primitive reflexes. INPP scale 0-4, 0 being no reflex retained and 4 being severe reflex retention
Measured: week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Apr 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be assigned to one of two groups. Each group will recieve the same minutes of treatment however one group will include reflex integration and one will include fine and gross motor intervention (standard OT treatment) only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Healey Miller, Salus University
- Investigators
- Healey Miller, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825248
- Sponsor's protocol ID
- H.Miller.2.27.23
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Protocols to Improve Reflex Integration and Functional Performance
- ClinicalTrials.gov ID
- NCT05825248
- Acronym / sponsor ID
- H.Miller.2.27.23
- Conditions
- Developmental Delay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 24 Apr 2023 (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 goal of this quantitative experimental study is to compare two occupational therapy interventions intended to improve functional skills. The main questions it aims to answer are:
Question 1: Do preschool children who participate in occupational therapy intervention designed to promote integration of the TLR reflex in conjunction with fine and gross motor intervention demonstrate improved integration of the TLR reflex in clinical assessment, compared to children who participate in fine and gross motor intervention only for an equal amount of time?
Question 2: Do preschool children who participate in occupational therapy intervention designed to promote integration of the TLR reflex in conjunction with fine and gross motor intervention demonstrate improved integration of the TLR reflex in clinical assessment, compared to children who participate in fine and gross motor intervention only for an equal amount of time?
Participants will participate in either a therapy program consisting of either fine and gross motor treatment in conjunction with reflex integration treatment, or fine and gross motor treatment only.
If there is a comparison group: Researchers will compare the group recieving reflex integration in conjunction with fine and gross motor treatment and the fine and gross motor only group to see if one is more effective at integrating the reflex and/or improving functional skills.
Detailed description
Pre-intervention, INPP screening for TLR will be administered to determine eligibility for the study and baseline of reflex persistence. the Peabody Developmental Motor Scales 2nd Edition (PDMS2) stationary and visual motor integration sections will be administered to assess fine and gross motor skills. Stratified random sampling will be used to create two parallel groups. Both the INPP and PDMS2 will be administered and scored by a masked examiner who is licensed to practice occupational therapy.
For 6 weeks, one group will receive 20 minutes standard occupational therapy intervention while the second group will receive 10 minutes of standard occupational therapy intervention and 10 minutes of TLR integration protocol (Move Play Thrive Program). 20 minutes per week is standard treatment time for preschool occupational therapy sessions in Aberdeen School District. Intervention will be provided by the PI, Healey Miller.
Post-intervention, the Peabody Developmental Motor Scales 2nd Edition (PDMS2) stationary and visual motor integration sections will be re-administered to assess fine and gross motor skills and the INPP screening for TLR will be re-administered to assess for retained TLR reflex. Both the INPP and PDMS2 will be administered and scored by a masked examiner who is licensed to practice occupational therapy. Data will be reviewed to determine if the progress made between groups, in regard to motor skills and reflex integration, is statistically significant. Data will be reviewed to compare progress made in each group in fine/gross motor skills and reflex integration, and to determine if changes made are statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants will be assigned to one of two groups. Each group will recieve the same minutes of treatment however one group will include reflex integration and one will include fine and gross motor intervention (standard OT treatment) only.
| Arm | Type | Receives |
|---|---|---|
| Reflex integration + fine and gross motor treatment | Experimental | Other: Reflex integration + fine and gross motor treatmentFor 20 minutes per week for 8 weeks, this group will recieve 10 minutes of fine and gross motor treatment and 10 minutes of reflex integration exercises from the Move Play Thrive program. |
| Fine and gross motor treatment only | Active comparator | Other: Fine and gross motor treatment onlyFor 20 minutes per week for 8 weeks, this group will recieve 20 minutes of standard occupational therapy treatment consisting of fine and gross motor intervention. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3 to <6 years old
- Attending preschool at Hopkins Preschool, Stevens Elementary Preschool, or Central Park Preschool within Aberdeen School District
- Receiving weekly occupational therapy services to address fine motor, gross motor, or sensory deficits
- Displays signs of retained tonic labyrinthine reflex (TLR) after a brief INNP TLR screening test (a score of 3, or 4 will be considered a retained TLR for the purpose of this study)
Key exclusion criteria (2 listed)
- Students enrolled in an alternative enrollment format
- Students who are absent for a consecutive period of 5 or more school days
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 and gross motor treatment onlyoccupational therapy intervention involving general fine and gross motor activities | Other | Fine and gross motor treatment only |
| Reflex integration + fine and gross motor treatmentAlso: Move, Play, Thrive reflex integration exercisesoccupational therapy intervention involving general fine and gross motor activities as well as targeted reflex integration exercises | Other | Reflex integration + fine and gross motor treatment |
Primary outcome
Change from baseline functional skills at 8 weeks
Time frame: week 0 and week 8
functional skills as measured by the Peabody Developmental Motor Scales Stationary and Visual Motor Integration sections. This standardized test scoring can be converted into z-scores for data comparison.
Change from baseline TLR inegration at 9 weeks
Time frame: week 0 and week 8
integration of the tonic labyrinthine reflex as measured by the INPP measure for retained primitive reflexes. INPP scale 0-4, 0 being no reflex retained and 4 being severe reflex retention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
Healey Miller principal investigator
Salus University
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 and gross motor treatment only and Reflex integration + fine and gross motor treatment in people with Developmental Delay, run by Salus 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 4 inclusion and 2 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 24 Apr 2023. 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?
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 from baseline functional skills at 8 weeks (time frame: week 0 and week 8). The study lists 2 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 24 Apr 2023.