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NCT02167022 · ClinicalTrials.gov registry record · NA

Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy

A NA study, sponsored by University of Arizona.

Completed
Registry status
NA
Development phase
90
Enrollment target

NCT02167022 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 90 participants.

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The verdict

NCT02167022, a NA study, has completed, sponsored by University of Arizona.

COMPLETED
Registry status
NA
Development phase
90 participants
Enrollment target

Study Summary

Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain when the brain is most rapidly developing and which results in some motor dysfunction. Causes for the injury to the brain are numerous and can occur prior to birth, during the birth process, or within the first few months following birth. The motor dysfunction can involve any or all four extremities but most often affects the legs, causing abnormal ambulation. The level of severity depends on the extent of the injury to the brain and can be mild to severe. In severe instances, the child is dependent on others for all his/her care. There is no known cure for CP, but physical and occupational therapies are administered in an attempt to improve function. The frequency of these therapies varies from once a week (the standard of care in the Western Hemisphere) to five times a week (the standard of care in Asia and some Eastern European countries). The current understanding of brain plasticity offers a theoretical explanation to justify the more intense approach. Active repetitive motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore some function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons and prevent their 'natural' degeneration in order for them to substitute for the function of injured neurons. It is the very young brain that is most likely to respond to this therapy. The aim of this proposal is to evaluate the effect of administering both physical and occupational therapy five times each week for 12 weeks and compare it with the standard of care (SOC) approach of one time each week in children between the ages of 12 months and 36 months. This is the first randomized crossover trial to both enroll this young a population of children with cerebral palsy as well as to evaluate this approach from both the therapists and the parents perspectives. The number of children that this study will enroll is larger than

Interventions

  • OTHER Physical and occupational therapy

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2014-09-30
Est. Completion 2021-07-31
Phase NA

Sponsor

University of Arizona

349 total trials

What the Registry Record Tells You About NCT02167022

The ClinicalTrials.gov registry entry for NCT02167022 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Physical and occupational therapy is the first listed.

NCT02167022 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02167022 about?

NCT02167022 is a clinical study titled "Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy". Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain when the brain is most rapidly developing and which results in some motor dysfunction. Causes for the injury to the brain are numerous and can occur prior to birth, during the birth process, or within the fi...

What is the current status of trial NCT02167022?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2014-09-30. Estimated completion is 2021-07-31.

What interventions are being tested in trial NCT02167022?

The interventions under investigation include: Physical and occupational therapy (OTHER).

Who is sponsoring clinical trial NCT02167022?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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