Author Names
Pastor-Pons I., Hidalgo-García C., Lucha-López M.O., Barrau-Lalmolda M., Rodes-Pastor I., Rodríguez-Fernández A.L., Tricás-Moreno J.M.
Reviewer Name
Abby Davis, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Background Positional plagiocephaly (PP) is a cranial deformation frequent amongst children and consisting in a flattened and asymmetrical head shape. PP is associated with excessive time in supine and with congenital muscular torticollis (CMT). Few studies have evaluated the efficiency of a manual therapy approach in PP. The purpose of this parallel randomized controlled trial is to compare the effectiveness of adding a manual therapy approach to a caregiver education program focusing on active rotation range of motion (AROM) and neuromotor development in a PP pediatric sample. Methods Thirty-four children with PP and less than 28 week-old were randomly distributed into two groups. AROM and neuromotor development with Alberta Infant Motor Scale (AIMS) were measured. The evaluation was performed by an examiner, blinded to the randomization of the subjects. A pediatric integrative manual therapy (PIMT) group received 10-sessions involving manual therapy and a caregiver education program. Manual therapy was addressed to the upper cervical spine to mobilize the occiput, atlas and axis. The caregiver educational program consisted in exercises to reduce the positional preference and to stimulate motor development. The control group received the caregiver education program exclusively. To compare intervention effectiveness across the groups, improvement indexes of AROM and AIMS were calculated using the difference of the final measurement values minus the baseline measurement values. If the distribution was normal, the improvement indexes were compared using the Student t-test for independent samples; if not, the Mann-Whitney U test was used. The effect size of the interventions was calculated using Cohen’s d. Results All randomized subjects were analysed. After the intervention, the PIMT group showed a significantly higher increase in rotation (29.68 ± 18.41°) than the control group (6.13 ± 17.69°) (p = 0.001). Both groups improved the neuromotor development but no statistically significant differences were found. No harm was reported during the study. Conclusion The PIMT intervention program was more effective in increasing AROM than using only a caregiver education program.
NIH Risk of Bias Tool
Quality Assessment of Controlled Intervention Studies
- Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- Cannot Determine, Not Reported, or Not Applicable
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Cannot Determine, Not Reported, or Not Applicable
- Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Yes
- Was there high adherence to the intervention protocols for each treatment group?
- Cannot Determine, Not Reported, or Not Applicable
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
- Cannot Determine, Not Reported, or Not Applicable
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Yes
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
- Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?
- Cannot Determine, Not Reported, or Not Applicable
Key Finding #1
Infants in the pediatric integrative manual therapy (PIMT) group had a statistically significant increase in right cervical rotation active range of motion compared to the control group.
Key Finding #2
There was no statistical difference in AIMS scores between the PIMT group and the control group.
Key Finding #3
Manual therapy focusing on mobilization of the occiput, C1, and C2 via traction and assistance in all head movements can be utilized along with strengthening exercises and caregiver education to treat infants with positional plagiocephaly.
Please provide your summary of the paper
This study sought to compare the effectiveness of pediatric integrative manual therapy (PIMT) to the cervical spine and caregiver education (including exercise therapy) on infants with moderate to severe positional plagiocephaly. PIMT included mobilization of the occiput, C1, and C2, utilizing some gentle distraction and moving the infant’s head into flexion, extension, side bending, and rotation once the infant moves into one of these directions. Physical therapists avoided end-range extension and rotation. For 10 weeks, the patients in the PIMT group had manual therapy once a week for 20 minutes. The control group received a program consisting of exercises that alter positional preference and augment development. This group met once more during the 10 weeks. The PIMT group also received the same program as the control group. Outcomes used to measure changes were AROM and the Alberta Infant Motor Scale. The results showed a statistically significant increase in right cervical AROM in the PIMT group compared to the control, although the baseline of the PIMT group’s right cervical AROM was lower than the control group. Additionally, there was no significant difference in AIMS score improvement over the 10 weeks between the groups.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
Based on the results of this study, cervical manual therapy appears effective in increasing active range of motion in infants with positional plagiocephaly. It may be beneficial for clinicians to include this in the treatment of these patients, alongside strengthening exercises and caregiver education, but is not necessarily crucial to treatment. There were no differences in the AIMS between the two groups, showing neither is more effective than the other in fostering neurodevelopment. Ideally, further studies should be completed with PIMT and long-term outcome to assess any neurodevelopment changes over time. Most important to note is for physical therapists to not move the infant into end range cervical extension and rotation during this therapy. Altogether, PIMT is an effective therapy that can assist physical therapists in treating restrictions of the cervical spine in infants with positional plagiocephaly.
