An interventional study of Passive Stretching and Perception-Action Approach in Congenital Muscular Torticollis, sponsored by Rosalind Franklin University of Medicine and Science. Terminated at 1 site in United States. Open to participants aged Up to 9 Months. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and Treatment
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:
There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:
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:
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-evaluation sessions will be video recorded for future analyses by an assessor blind to the infants' group assignment. Such analyses will include still photography measurements, assessment of motor development using the Alberta Infant Motor Scale (AIMS), and assessment of symmetrical use of both sides of the body using the Functional Symmetry Observation Scale (FSOS). Treating therapists will perform "live" active head rotation and muscle strength measurements, for which assessor blinding will not be possible. In addition, each infant's behavior exhibited during therapy will be assessed by the treating therapist at intervention sessions 2-4. Results obtained from the two groups will be compared.
At the first PT visit, the treating therapist will conduct a PT evaluation, educate the caregiver in proper positioning and benefits of tummy time, and provide intervention specific to the infant's group assignment. For the Passive Stretching Group, intervention will include caregiver instruction in passive stretching for lateral flexion and rotation of the neck, with the parent practicing the techniques. For the P-A Approach Group, intervention will include the interpretation of the infant's behavior for the caregiver while manual guidance is provided to the infant. At 3 subsequent PT sessions, group-specific intervention and continued caregiver instruction will be provided. Passive Stretching Group intervention components will include passive stretching and associated strengthening activities. P-A Approach Group intervention components will include environmental set-up and manual guidance. At the final PT visit in the study, a PT re-evaluation will be conducted, followed by group-specific intervention as needed.
Prior to initiating the RCT, a pilot study will be conducted to establish the intrarater, test-retest or inter-rater reliability of the outcome measures, as appropriate. A total of 10 infants with CMT will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a Fidelity of Intervention Checklist to ensure the treating therapists' adherence to the strategies outlined as essential elements of each of the intervention approaches. In addition, during the main study, intervention adherence will be assessed by tracking the participants' attendance, the PT session length and frequency, and the total duration of each subject's research participation.
Exclusion Criteria:
Passive Stretching intervention components include static passive stretching, active assistive range of motion, assisted stretching of the involved cervical musculature, and associated strengthening activities aimed to elicit head righting in developmentally appropriate positions and during developmentally appropriate movement transitions. Intervention is progressed by increasing head tilt angles, duration of head righting, and frequency and number of repetitions.
Behavioral: Passive Stretching
P-A Approach intervention components include environmental set-up for activity and participation in play, and manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions. Both components are designed to promote spontaneous exploration of the environment by the infant by suggesting small, incremental changes in his/her perceptual-motor orientation and contact with the support surface. Intervention is progressed by gradually removing environmental supports provided to the infant's body parts, and by removing the therapist's hands from the infant's body to allow for spontaneous exploration of a newly found contact with the support surface or new body configuration.
Behavioral: Perception-Action Approach
Passive stretching and associated strengthening activities to change head/neck and body alignment
Also known as: Passive movement, physical therapy
Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities
Also known as: Perceptual-motor intervention, physical therapy
Still Photography
Change in the angle of habitual head deviation from midline assessed in a supine position
Time frame: At baseline and week 5
Arthrodial Goniometry
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Time frame: At baseline and week 5
Muscle Function Scale (MFS)
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
Time frame: At baseline and week 5
Functional Symmetry Observation Scale (FSOS)
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
Time frame: At baseline and week 5
Alberta Infant Motor Scale (AIMS)
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
Time frame: At baseline and week 5
Therapy Behavior Scale (TBS)
The TBS score documents therapy-related behavior during intervention sessions; to be used for between group comparison only.
Time frame: Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4)
Plan to share: No — There is not a plan to make IPD available.
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Rosalind Franklin University of Medicine and Science