Comparing Two Protocols to Improve Reflex Integration and Functional Performance

NCT05825248 | Unknown

• 1 other identifier: H.Miller.2.27.23
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Delay

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Other: Fine and gross motor treatment only

Interventions

Fine and gross motor treatment only OTHER

occupational therapy intervention involving general fine and gross motor activities

Fine and gross motor treatment only

Reflex integration + fine and gross motor treatment OTHER

occupational therapy intervention involving general fine and gross motor activities as well as targeted reflex integration exercises

Also known as: Move, Play, Thrive reflex integration exercises

Reflex integration + fine and gross motor treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Aberdeen School District

Aberdeen, Washington, 98520, United States

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Healey Miller

  Salus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be administered and scored by a masked examiner who is licensed to practice occupational therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 24, 2023
• Study Start: April 10, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)