TerminatedNot Applicable

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

Stopped: Study stopped due to COVID-19 pandemic and will not resume.

United States32 participantsStarted 2016-08-04

Plain-language 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

Who can participate

Age range

9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Still Photography

Timeframe: At baseline and week 5

Arthrodial Goniometry

Timeframe: At baseline and week 5

Muscle Function Scale (MFS)

Timeframe: At baseline and week 5

Functional Symmetry Observation Scale (FSOS)

Timeframe: At baseline and week 5

Alberta Infant Motor Scale (AIMS)

Timeframe: At baseline and week 5

Trial details

NCT IDNCT02824848

SponsorRosalind Franklin University of Medicine and Science

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-02

View on ClinicalTrials.gov More Congenital Muscular Torticollis trials

Plain-language summary

Who can participate

Age range

9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Still Photography

Timeframe: At baseline and week 5

Arthrodial Goniometry

Timeframe: At baseline and week 5

Muscle Function Scale (MFS)

Timeframe: At baseline and week 5

Functional Symmetry Observation Scale (FSOS)

Timeframe: At baseline and week 5

Alberta Infant Motor Scale (AIMS)

Timeframe: At baseline and week 5