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NCT00347334 · ClinicalTrials.gov registry record
Is Home Positioning Time Associated With Torticollis Rate of Recovery?
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 150
- Enrollment target
NCT00347334 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 150 participants.
The verdict
NCT00347334 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
The term torticollis is Latin for "twisted neck". It can be caused by a tightness of the sternocleidomastoid muscle manifested by a head tilt to the same and neck rotation to the opposite side. Treatment includes a comprehensive physical therapy program. Torticollis typically presents itself within the first three months of life. Currently research in infants concludes that a physical therapy stretching program is effective in the majority of cases.1 The study will determine how positioning time correlates to rate of recovery. Overall incidence of torticollis has increased dramatically since the inception of the back to sleep program in 1994.2 The back to sleep program is an educational awareness program promoting families to place infants to sleep on their backs to reduce the risks of sudden infant death. The increase use of semi-upright positioning equipment prior to developmental head control may also be contributing to the increase. Families are placing babies in semi-upright position ie. car seat or swing prior to developmental head control. Head control typically emerges by three months of age. Unfortunately the use of positioning devices occurs prior to the child reaching their third month birthday. The specific aims of the study will include measuring the rate of recovery for infant torticollis. Recovery will be defined as achieving full neck rotation and no head tilt. The length of time spent in developmental positions and positioning equipment such as belly lying, side lying, semi-upright and sitting will also be monitored and recorded. No specific position will be prescribed; the study will monitor positions only. Treatment will be initiated upon referral to Cleveland Clinic Children's Hospital for physical therapy evaluation. Baseline for cervical rotation and lateral tilt will be assessed. Families will be trained regarding a home stretching program and asked to diary home positioning time. Routine plan of care will continue a minimum of every other
Interventions
- BEHAVIORAL infant home positioning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00347334
The ClinicalTrials.gov registry entry for NCT00347334 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which infant home positioning is the first listed.
NCT00347334 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00347334 about?
NCT00347334 is a clinical study titled "Is Home Positioning Time Associated With Torticollis Rate of Recovery?". The term torticollis is Latin for "twisted neck". It can be caused by a tightness of the sternocleidomastoid muscle manifested by a head tilt to the same and neck rotation to the opposite side. Treatment includes a comprehensive physical therapy program. Torticollis typically presents itself within ...
What is the current status of trial NCT00347334?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2006-03. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00347334?
The interventions under investigation include: infant home positioning (BEHAVIORAL).
Who is sponsoring clinical trial NCT00347334?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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