NCT05070910

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

September 23, 2021

Last Update Submit

January 27, 2023

Conditions

Cerebral PalsyNeuromuscular DiseasesNeurodevelopment Treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

NDT

EXPERIMENTAL

Therapy will be provided 2 days to 4 days per week for one-hour sessions

Behavioral: Therapy

Interventions

TherapyBEHAVIORAL

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

NDT

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Puyallup, Washington, 98372, United States

Location

MeSH Terms

Conditions

Cerebral PalsyNeuromuscular Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 7, 2021

Study Start

October 25, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

US(1)