Is Home Positioning Time Associated With Torticollis Rate of Recovery?

NCT00347334 | Completed

• 1 other identifier: 05-209
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Torticollis

Keywords

Torticollis; infant home positioning; head control

Interventions

infant home positioning BEHAVIORAL

Eligibility Criteria

• Age: 5 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of torticollis
• months of age or less

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Cleveland Clinic Children's Hospital - East location

Beachwood, Ohio, 44122, United States

Location

Cleveland Clinic Children's Hospital - Shaker campus

Cleveland, Ohio, 44104, United States

Location

Cleveland Clinic Children's Hospital - Westlake

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Marie S Pace, MPT

  Cleveland Clinic Foundation - Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 28, 2016

Record last verified: 2014-01

Locations

US (3)