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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00347334 |
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 week until full active range of motion is achieved. At each visit cervical range of motion will be determined as well as parent report regarding home positioning time. Recovery will be defined as full active range of motion, no head tilt, and symmetrical head righting reactions. Post recovery analysis of recovery rates and positioning time will be done to assess correlations.
Condition | Intervention | Phase |
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Torticollis |
Behavioral: infant home positioning |
Phase I |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Is Home Positioning Time Associated With Torticollis Rate of Recovery? |
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Cleveland Clinic Children's Hospital - Shaker campus | |
Cleveland, Ohio, United States, 44104 | |
Cleveland Clinic Children's Hospital - Westlake | |
Westlake, Ohio, United States, 44145 | |
Cleveland Clinic Children's Hospital - East location | |
Beachwood, Ohio, United States, 44122 |
Principal Investigator: | Ann Marie S Pace, MPT | Cleveland Clinic Foundation - Children's Hospital |
Study ID Numbers: | 05-209 |
Study First Received: | June 29, 2006 |
Last Updated: | November 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00347334 History of Changes |
Health Authority: | United States: Institutional Review Board |
Torticollis infant home positioning head control |
Dystonic Disorders Signs and Symptoms Torticollis Movement Disorders |
Neurologic Manifestations Central Nervous System Diseases Dystonia Dyskinesias |
Dystonic Disorders Signs and Symptoms Torticollis Movement Disorders Nervous System Diseases |
Neurologic Manifestations Dystonia Central Nervous System Diseases Dyskinesias |