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

Summary

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

Conditions

• Congenital Muscular Torticollis

Interventions

BEHAVIORAL

Passive Stretching

Passive stretching and associated strengthening activities to change head/neck and body alignment

BEHAVIORAL

Perception-Action Approach

Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities

Sponsors & Collaborators

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Rosalind Franklin University of Medicine and Science

  lead OTHER

Principal Investigators

• Mary Rahlin, PT, DHS, PCS · Rosalind Franklin University of Medicine and Science

• Nancy Haney, PT, MS · Rady Children' Hospital, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

9 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-04

Primary Completion

2020-03-02

Completion

2020-05-06

Countries

• United States

Study Locations