Back to resultsNDT Effectiveness Study
Primary Purpose
Cerebral Palsy, Neuromuscular Diseases, Neurodevelopment Treatment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NDT
Arm Description
Therapy will be provided 2 days to 4 days per week for one-hour sessions
Outcomes
Primary Outcome Measures
Significant increase in functional outcomes in COPM scores
Change functional outcomes in COPM scores after NDT-CPM treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT05070910
First Posted
September 23, 2021
Last Updated
January 27, 2023
Sponsor
MultiCare Health System Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05070910
Brief Title
NDT Effectiveness Study
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Neuromuscular Diseases, Neurodevelopment Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NDT
Arm Type
Experimental
Arm Description
Therapy will be provided 2 days to 4 days per week for one-hour sessions
Intervention Type
Behavioral
Intervention Name(s)
Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Significant increase in functional outcomes in COPM scores
Description
Change functional outcomes in COPM scores after NDT-CPM treatment.
Time Frame
Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
12. IPD Sharing Statement
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NDT Effectiveness Study
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