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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial

Brief 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 Sca

      Detailed Summary:

      This prospective longitudinal study will be a two-group, single-blind, pre-post-test design randomized clinical trial (RCT). The purpose of this study will be two-fold:

      1. To compare the efficacy of passive stretching and Perception-Action (P-A) Approach interventions in improving postural alignment, symmetrical use of both sides of the body during movement and play, and gross motor development in infants with congenital muscular torticollis (CMT)
      2. To compare therapy-related behavior in infants with CMT undergoing passive stretching and P-A Approach interventions during physical therapy (PT) sessions

      Within group comparisons will be made to assess change over time, and between group comparisons will be made to compare the effects of the two interventions. Both interventions are used in the clinic for infants with CMT but it is not known whether they are equally effective or if one is more effective than the other.

      Thirty-six consecutively enrolled infants with CMT will be randomly assigned to a Passive Stretching group or a P-A Approach group using a blocked randomization procedure. Each infant will attend 5 weekly 60-minute PT sessions, including the initial evaluation, 3 interventions sessions, and a re-evaluation. The total duration of each participant's involvement in the study will be approximately 1-2 months. At visits 1 and 5, each infant's habitual head deviation from midline, active head rotation to both sides, neck muscle strength on both sides, motor development, and symmetrical use both sides of the body for movement and play will be assessed.

      Participants' photos will be taken in a supine position and parts of the initial PT evaluation and re-
      Sponsor: Rosalind Franklin University of Medicine and Science

      Current Primary Outcome:

      • Still Photography [ Time Frame: At baseline and week 5 ]
        Change in the angle of habitual head deviation from midline assessed in a supine position
      • Arthrodial Goniometry [ Time Frame: At baseline and week 5 ]
        Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
      • Muscle Function Scale (MFS) [ Time Frame: At baseline and week 5 ]
        Change in the MFS score that reflects the difference in strength of lateral neck flexor muscles during head righting between the involved and uninvolved sides
      • Functional Symmetry Observation Scale (FSOS) [ Time Frame: At baseline and week 5 ]
        Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
      • Alberta Infant Motor Scale (AIMS) [ Time Frame: At baseline and week 5 ]
        Change in the AIMS score that reflects gross motor development while also considering symmetrical postural alignment and symmetrical use of both sides of the body during movement and play


      Original Primary Outcome:

      • Still Photography [ Time Frame: 5 weeks ]
        Change in the angle of habitual head deviation from midline assessed in a supine position
      • Arthrodial Goniometry [ Time Frame: 5 weeks ]
        Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
      • Muscle Function Scale (MFS) [ Time Frame: 5 weeks ]
        Change in the MFS score that reflects the difference in strength of lateral neck flexor muscles during head righting between the involved and uninvolved sides
      • Functional Symmetry Observation Scale (FSOS) [ Time Frame: 5 weeks ]
        Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
      • Alberta Infant Motor Scale (AIMS) [ Time Frame: 5 weeks ]
        Change in the AIMS score that reflects gross motor development while also considering symmetrical postural alignment and symmetrical use of both sides of the body during movement and play


      Current Secondary Outcome: Therapy Behavior Scale (TBS) [ Time Frame: Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4) ]

      The TBS score documents therapy-related behavior during intervention sessions; to be used for between group comparison only.


      Original Secondary Outcome: Therapy Behavior Scale (TBS) [ Time Frame: Weeks 2, 3 and 4 (at time of intervention sessions 2, 3 and 4) ]

      The TBS score documents therapy-related behavior during intervention sessions; to be used for between group comparison only.


      Information By: Rosalind Franklin University of Medicine and Science

      Dates:
      Date Received: July 2, 2016
      Date Started: July 2016
      Date Completion: July 2018
      Last Updated: May 7, 2017
      Last Verified: May 2017