NCT02907801

Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Rosalind Franklin University of Medicine and Science · Academic / Other
• Sex: All
• Age: 9 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Congenital Muscular Torticollis

Interventions

Type	Name	Description
BEHAVIORAL	Perception-Action Approach	Environmental set-up, gentle manual guidance, and caregiver education

Timeline

• Start date: 2017-01-10
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2016-09-20
• Last updated: 2018-08-13

Locations

1 site across 1 country: United States