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

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ClinicalTrials.gov Identifier: NCT02824848
Recruitment Status : Terminated (Study stopped due to COVID-19 pandemic and will not resume.)
First Posted : July 7, 2016
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Rady Children's Hospital, San Diego
Information provided by (Responsible Party):
Mary Rahlin, Rosalind Franklin University of Medicine and Science

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 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

Condition or disease Intervention/treatment Phase
Congenital Muscular Torticollis Behavioral: Passive Stretching Behavioral: Perception-Action Approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial
Actual Study Start Date : August 4, 2016
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : May 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Passive Stretching
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
Passive stretching and associated strengthening activities to change head/neck and body alignment
Other Name: Passive movement, physical therapy

Active Comparator: Perception-Action Approach
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
Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities
Other Name: Perceptual-motor intervention, physical therapy




Primary Outcome Measures :
  1. Still Photography [ Time Frame: At baseline and week 5 ]
    Change in the angle of habitual head deviation from midline assessed in a supine position

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824848


Locations
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United States, California
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Rady Children's Hospital, San Diego
Investigators
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Principal Investigator: Mary Rahlin, PT, DHS, PCS Rosalind Franklin University of Medicine and Science
Principal Investigator: Nancy Haney, PT, MS Rady Children' Hospital, San Diego
Publications:

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Responsible Party: Mary Rahlin, Associate Professor, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT02824848    
Other Study ID Numbers: 421 PT
160161 ( Other Identifier: UCSD Human Research Protections Program )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Keywords provided by Mary Rahlin, Rosalind Franklin University of Medicine and Science:
congenital muscular torticollis
infants
passive stretching
perception-action approach
Additional relevant MeSH terms:
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Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms