TerminatedNot Applicable

Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis

Stopped: After a reliability pilot, main study stopped due to unrelated clinic closure.

United States5 participantsStarted 2017-01-10

Plain-language summary

Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. This study will investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion, and functional use of both sides of the body in infants with CMT. The participants will be 3 infants with CMT, aged birth to 9 months. A randomized, nonconcurrent A-B multiple baseline design across subjects will be used. The intervention phase will include 5 daily PT sessions, with outcome data collected at the end of each session. It is hypothesized that improvements on all outcome measures will be documented upon the initiation of the P-A Approach intervention, with the most substantial change expected in habitual head deviation from midline measured by still photography.

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 CMT as documented in the medical record * parents/guardians agree not to have their child participate in any additional interventions for CMT during the course of the study Exclusion Criteria: * diagnosis of neuromuscular torticollis, Sandifer syndrome, acute torticollis, benign paroxysmal torticollis, ocular torticollis, torticollis related to bony anomalies, or another non-muscular type of torticollis * being seen for torticollis by another health care provider * receiving a passive stretching intervention for CMT prior to referral for PT at the research site

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: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Arthrodial Goniometry

Timeframe: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Functional Symmetry Observation Scale (FSOS)

Timeframe: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Trial details

NCT IDNCT02907801

SponsorRosalind Franklin University of Medicine and Science

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-26

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: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Arthrodial Goniometry

Timeframe: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Functional Symmetry Observation Scale (FSOS)

Timeframe: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)