Comparing Two Protocols to Improve Reflex Integration and Functional Performance

Developmental Delay Clinical Trial

Official title:

Comparing Two Protocols to Improve Reflex Integration and Functional Performance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05825248
• Other study ID #: H.Miller.2.27.23
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: April 2023
• Source: Salus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Other:
• Fine and gross motor treatment only
occupational therapy intervention involving general fine and gross motor activities
• Reflex integration + fine and gross motor treatment
occupational therapy intervention involving general fine and gross motor activities as well as targeted reflex integration exercises

Locations

Country	Name	City	State
United States	Aberdeen School District	Aberdeen	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Salus University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 0 and week 8
Primary	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	week 0 and week 8