Clinical trial NCT05825248: Comparing Two Protocols to Improve Reflex Integration and Functional Performance
Official title: Comparing Two Protocols to Improve Reflex Integration and Functional Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Delay
Lead sponsor: Salus University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Students enrolled in an alternative enrollment format
* Students who are absent for a consecutive period of 5 or more school days

Primary outcomes:
measure: Change from baseline functional skills at 8 weeks
timeFrame: week 0 and week 8
measure: Change from baseline TLR inegration at 9 weeks
timeFrame: week 0 and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United States
facility: Aberdeen School District
state: Washington
Study officials:
affiliation: Salus University
name: Healey Miller
role: PRINCIPAL_INVESTIGATOR
References: