Is Home Positioning Time Associated With Torticollis Rate of Recovery?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00347334
First received: June 29, 2006
Last updated: November 8, 2007
Last verified: November 2007
  Purpose

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
Torticollis
Behavioral: infant home positioning
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Is Home Positioning Time Associated With Torticollis Rate of Recovery?

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Estimated Enrollment: 150
Study Start Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of torticollis
  • 6 months of age or less

Exclusion Criteria:

  • previous surgery
  • treatment initiated at another facility
  • medical complication which interfere with treatment
  • radiology results of vertebral anomaly, ocular imbalance of nerve injury
  • compliance with less than 80% scheduled sessions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347334

Locations
United States, Ohio
Cleveland Clinic Children's Hospital - East location
Beachwood, Ohio, United States, 44122
Cleveland Clinic Children's Hospital - Shaker campus
Cleveland, Ohio, United States, 44104
Cleveland Clinic Children's Hospital - Westlake
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Ann Marie S Pace, MPT Cleveland Clinic Foundation - Children's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347334     History of Changes
Other Study ID Numbers: 05-209
Study First Received: June 29, 2006
Last Updated: November 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Torticollis
infant home positioning
head control

Additional relevant MeSH terms:
Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014