An interventional study of Perception-Action Approach in Congenital Muscular Torticollis, sponsored by Rosalind Franklin University of Medicine and Science. Terminated at 1 site in United States. Open to participants aged Up to 9 Months. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Perception-Action Approach (P-AA) intervention components include environmental set-up for activity and participation in play, manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions, and caregiver education in modifications to everyday activities consistent with the P-AA. All 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 the environmental supports and therapist's hands 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, gentle manual guidance, and caregiver education
Also known as: Perceptual-motor intervention, physical therapy
Still Photography
Change in the angle of habitual head deviation from midline assessed in a supine position
Time frame: 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
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Time frame: 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)
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
Time frame: 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)
Therapy Behavior Scale (TBS), Version 2.2
The TBS score documents therapy-related behavior during intervention sessions
Time frame: 5 days (assessed after each of 5 intervention sessions)
Plan to share: Undecided
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Rosalind Franklin University of Medicine and Science