Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis

Stopped early · Not applicable

Conditions studied: Congenital Muscular Torticollis

In brief

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 sides of the body for movement and play 4. The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than the passive stretching group assigned based on participants' behavior demonstrated during PT intervention sessions

Key facts

Study ID

NCT02824848

Run by

Rosalind Franklin University of Medicine and Science

People needed

32

Starts

2016-08-04

Expected to finish

2020-05-06

Last updated by the study team

2020-05-12

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age between birth and 9 months at the time of recruitment
• diagnosis of congenital muscular torticollis as documented in the medical record
• Parents agree not to have their child participate in any additional interventions for CMT during the course of the study

You may not qualify if…

• other types of torticollis, such as neuromuscular torticollis, Sandifer syndrome, benign paroxysmal torticollis, ocular torticollis and other non-muscular types of torticollis, such as related to bony anomalies, which would warrant a referral back to the referring physician or to an appropriate specialist for diagnosis
• being seen for torticollis by another health care provider
• parents were using passive stretching with their infant prior to the study being offered to them AND would like to continue with passive stretching, but the child is assigned to the other intervention group
• parents were using Perception-Action Approach with their infant prior to the study being offered to them AND would like to continue with the same approach but the child is assigned to the other intervention group
• the child is found to meet the exclusion criteria at any time during the clinical trial

Where it is running

• Rady Children's Hospital, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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