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Comparing Two Protocols to Improve Reflex Integration and Functional Performance

NCT05825248 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-04-24

No results posted yet for this study

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

Interventions

OTHER

Fine and gross motor treatment only

occupational therapy intervention involving general fine and gross motor activities

OTHER

Reflex integration + fine and gross motor treatment

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

Sponsors & Collaborators

  • Salus University

    lead OTHER

Principal Investigators

  • Healey Miller · Salus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2023-06-15
Completion
2023-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825248 on ClinicalTrials.gov