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NCT02824848 · ClinicalTrials.gov registry record · NA
Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis
A NA study, sponsored by Rosalind Franklin University of Medicine and Science.
- Terminated
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT02824848 is a NA study that was terminated before completion, run by Rosalind Franklin University of Medicine and Science. The registered enrollment target is 32 participants.
The verdict
NCT02824848, a NA study, was terminated before completion, sponsored by Rosalind Franklin University of Medicine and Science.
- TERMINATED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. In this randomized clinical trial, researchers will compare two physical therapy (PT) treatment methods, passive stretching and Perception-Action (P-A) Approach, in their effects on head position and use of both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly assigned to a passive stretching group or a P-A Approach group. The infants in both groups will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head position, the ability to turn the head to both sides, muscle strength on both sides of the neck, motor development, and use of both sides of the body for movement and play will be assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4. Results obtained from the two groups will be compared. It is hypothesized that: 1. There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures: 1. Still photography 2. Arthrodial goniometry used to assess active head rotation to both sides 3. The Muscle Function Scale (MFS) used to assess neck muscle strength 4. The Alberta Infant Motor Scale (AIMS) used to assess motor development 2. There will be no significant difference between the groups on the above listed measures after the intervention is completed. 3. The P-A Approach group will achieve greater gains than the passive stretching group between the initial and final assessments on the Functional Symmetry Observation Scale (FSOS) used to assess the use of both
Interventions
- BEHAVIORAL Passive Stretching
- BEHAVIORAL Perception-Action Approach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-08-04 |
| Est. Completion | 2020-05-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02824848
The ClinicalTrials.gov registry entry for NCT02824848 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rosalind Franklin University of Medicine and Science, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Passive Stretching is the first listed.
NCT02824848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02824848 about?
NCT02824848 is a clinical study titled "Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis". Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. In this randomized clinical trial, researchers w...
What is the current status of trial NCT02824848?
This trial is currently terminated. It is a NA study. The enrollment target is 32 participants. The study started on 2016-08-04. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT02824848?
The interventions under investigation include: Passive Stretching (BEHAVIORAL), Perception-Action Approach (BEHAVIORAL).
Who is sponsoring clinical trial NCT02824848?
This trial is sponsored by Rosalind Franklin University of Medicine and Science, which has 8 total clinical trials registered on ClinicalTrials.gov.
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