Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis

Congenital Muscular Torticollis Clinical Trial

— P-AA  

Official title:

Effects of Perception-Action Approach Intervention in Infants With Congenital Muscular Torticollis: A Randomized Nonconcurrent Multiple Baseline Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02907801
• Other study ID #: 433 PT
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: March 26, 2018

Study information

• Verified date: August 2018
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will have a randomized, nonconcurrent A-B multiple baseline design across subjects. The purpose of this study will be to investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion (ROM), 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, recruited from a private pediatric physical therapy (PT) practice. Baseline and intervention data will be collected 5 days per week, Monday through Friday, until the study is completed. The length of the baseline phase will be randomly assigned to each consecutively enrolled participant. The appropriate measurements will be taken at every baseline phase session but no intervention will be provided until the intervention phase is initiated. The intervention phase will include 5 daily PT sessions during which the P-AA intervention will be used, with outcome data collected at the end of each session. Additionally, the participants' therapy-related behavior during intervention sessions will be documented.

Measurements of still photos and scoring of video recordings to evaluate the participants' habitual head deviation from midline and functional use of both sides of the body for movement and play will be performed by an assessor blind to the timing of when the photos and videos are obtained within the study. The active head rotation ROM measurements and assessment of therapy-related behavior will be performed by the treating therapists.

Prior to initiating this research, a pilot reliability study will be conducted for all outcome measures. A total of 3 to 5 infants will be recruited for the pilot project.

Fidelity of intervention will be evaluated during the pilot study using a checklist. During the main study, intervention adherence will be assessed by tracking attendance, session duration, and intervention frequency.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Muscular Torticollis
• Torticollis

Intervention

Behavioral:
• Perception-Action Approach
Environmental set-up, gentle manual guidance, and caregiver education

Locations

Country	Name	City	State
United States	Ability Pediatric Physical Therapy, LLC	Anchorage	Alaska

Sponsors (2)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	Ability Pediatric Physical Therapy, LLC

Country where clinical trial is conducted

United States, 

References & Publications (6)

Kaplan SL, Coulter C, Fetters L. Physical therapy management of congenital muscular torticollis: an evidence-based clinical practice guideline: from the Section on Pediatrics of the American Physical Therapy Association. Pediatr Phys Ther. 2013 Winter;25(4):348-94. doi: 10.1097/PEP.0b013e3182a778d2. Review. — View Citation

Rahlin M, McCloy C, Henderson R, Long T, Rheault W. Development and content validity of the Therapy Behavior Scale. Infant Behav Dev. 2012 Jun;35(3):452-65. doi: 10.1016/j.infbeh.2012.03.001. Epub 2012 Jun 26. — View Citation

Rahlin M, Sarmiento B. Reliability of still photography measuring habitual head deviation from midline in infants with congenital muscular torticollis. Pediatr Phys Ther. 2010 Winter;22(4):399-406. doi: 10.1097/PEP.0b013e3181f9d72d. — View Citation

Rahlin M. TAMO therapy as a major component of physical therapy intervention for an infant with congenital muscular torticollis: a case report. Pediatr Phys Ther. 2005 Fall;17(3):209-18. Erratum in: Pediatr Phys Ther. 2005 Winter;17(4):257. — View Citation

Romeiser Logan L, Hickman RR, Harris SR, Heriza CB. Single-subject research design: recommendations for levels of evidence and quality rating. Dev Med Child Neurol. 2008 Feb;50(2):99-103. doi: 10.1111/j.1469-8749.2007.02005.x. Erratum in: Dev Med Child Neurol. 2009 Mar;51(3):247. — View Citation

Tscharnuter I. Clinical Application of Dynamic Theory Concepts According to Tscharnuter Akademie for Movement Organization (TAMO) Therapy. Pediatr Phys Ther. 2002 Spring;14(1):29-37. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Still Photography	Change in the angle of habitual head deviation from midline assessed in a supine position	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)
Primary	Arthrodial Goniometry	Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides	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)
Primary	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	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)
Secondary	Therapy Behavior Scale (TBS), Version 2.2	The TBS score documents therapy-related behavior during intervention sessions	5 days (assessed after each of 5 intervention sessions)