Cerebral PalsyNCT05070910
NDT Effectiveness Study
A study testing Therapy in people with Cerebral Palsy and Neuromuscular Diseases, run by MultiCare Health System Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Cerebral Palsy, Neuromuscular Diseases, Neurodevelopment Treatment
- What is being tested?
- Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Parent/Guardian unable to complete the 4 required interview sessions.
- Unable to commit to attending 75% of practicum sessions.
Trial locations and contacts
1 site in 1 country.
About this 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.
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).
- Being tested
- Therapy
- Medical subject headings
- Cerebral Palsy, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| NDT | Experimental | Therapy will be provided 2 days to 4 days per week for one-hour sessions Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant increase in functional outcomes in COPM scores
Change functional outcomes in COPM scores after NDT-CPM treatment.
Measured: Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start25 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070910
- Sponsor's protocol ID
- 2021/04/10
- Status last verified
- Jan 2023
- First submitted
- 23 Sep 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05070910
- Acronym / sponsor ID
- 2021/04/10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NDT | Experimental | Behavioral: TherapyTherapy will be provided 2 days to 4 days per week for one-hour sessions |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Parent/Guardian unable to complete the 4 required interview sessions.
- Unable to commit to attending 75% of practicum sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TherapyThe 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 | Behavioural | NDT |
Primary outcome
Significant increase in functional outcomes in COPM scores
Time frame: Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022
Change functional outcomes in COPM scores after NDT-CPM treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy in people with Cerebral Palsy and Neuromuscular Diseases, run by MultiCare Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant increase in functional outcomes in COPM scores (time frame: Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.