NDT Effectiveness Study

Determining the Efficacy of the Neurodevelopmental Treatment Contemporary Practice Model for the Treatment of Children With Cerebral Palsy or Other Neuromuscular Conditions to Improve Functional Outcomes.

The purpose of this study is to determine whether there is a functional change in children with Cerebral Palsy (CP) and other neuromuscular disorders participating in Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Neuromuscular Diseases; Neurodevelopment Treatment
• Intervention / Treatment: Behavioral: Therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Puyallup, Washington, United States, 98372
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The children will be aged 2 to 15 years with a diagnosis of CP, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified.
• Children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request.
• Children and their families are available and willing to attend the practicum portion of the course for both blocks.

Exclusion Criteria:

• Parent/Guardian unable to complete the 4 required interview sessions.
• Unable to commit to attending 75% of practicum sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NDT; Therapy will be provided 2 days to 4 days per week for one-hour sessions	Behavioral: Therapy; The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant increase in functional outcomes in COPM scores	Change functional outcomes in COPM scores after NDT-CPM treatment.	Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022

Collaborators and Investigators

• Sponsor: MultiCare Health System Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Neuromuscular Diseases
• Other Study ID Numbers: 2021/04/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No