An interventional study of Pediatric Integrative Manual Therapy and educational therapy and Stretching and educational therapy in Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional and Congenital Muscular Torticollis, sponsored by Universidad de Zaragoza. Status unknown at 1 site in Spain. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants. 25 participants will receive a protocol of Pediatric Integrative Manual Therapy and educational physiotherapy in combination, while the other 25 will receive a stretching protocol and educational physiotherapy
The Manual Therapy has shown efficacy in different pathologies in the adult but it is not know its utility in infants and children population, nor in specific pathologies as non synostotic plagiocephaly.
In the conservative treatment of plagiocephaly the educational physiotherapy and the helmet therapy have the better level of evidence among other treatments. When babies present preferential position of the head or Congenital Muscular Torticollis, stretching has shown efficacy.
A protocol of ten sessions of Pediatric Manual Therapy will be applied to infants with positional plagiocephaly in combination with educational physiotherapy. The protocol consists in soft cervical mobilisation, myofascial induction and the application of some pressures to the cranial bones to improve the asymmetry of the head. Educational therapy which consists in more "tummy time" stimulation, stimulation to the non preference position of the head and counter positioning. The control group will receive a protocol of stretching at home done by their parents and Educational therapy.
21 studies on the registry are indexed under Congenital torticollis; 4 are open to participants now.
This study's planned enrollment of 50 is above the median of 32 across 12 interventional studies indexed under Congenital torticollis.
Browse Congenital torticollis studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
10 sessions of Pediatric Manual Therapy, once a week. Soft cervical mobilisation, myofascial induction and cranial techniques will be administered. Educational physiotherapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be also administered.
Procedure: Pediatric Integrative Manual Therapy and educational therapy
A protocol of Stretching at home. 3-5 sessions twice a day. Each stretch will be maintain10 to 30 seconds. Each session 15 will take no less than 15 minutes. 7 days a week. Educational Physical Therapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be administered.
Procedure: Stretching and educational therapy
Pediatric Integrative Manual Therapy is a soft Orthopedic Manual Therapy approach por infants and children. It integrates joints soft mobilisation, myofascial release and neurodynamic mobilisation. Also the educational therapy.
It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.
Right Oblique Cranial Vault Diameter
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Time frame: 4 weeks
Right Oblique Cranial Vault Diameter
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Time frame: 10 weeks
Left Oblique Cranial Vault Diameter
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Time frame: 4 weeks
Left Oblique Cranial Vault Diameter
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Time frame: 10 weeks
Active Cervical Rotation Range of movement
Measured with photographs and digital angular analysis
Time frame: 4 weeks
Active Cervical Rotation Range of movement
Measured with digital angular analysis
Time frame: 10 weeks
Passive Cervical Rotation Range of movement
Measured lying down with joint goniometer
Time frame: 4 weeks
Passive Cervical Rotation Range of movement
Measured lying down with joint goniometer
Time frame: 10 weeks
Passive Cervical Lateral Flexion Range of movement
Measured lying down with joint goniometer
Time frame: 4 weeks
Passive Cervical Lateral Flexion Range of movement
Measured lying down with joint goniometer
Time frame: 10 weeks
Muscle Function Test
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Time frame: 4 weeks
Muscle Function Test
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Time frame: 10 weeks
Cranial length
Measured with calliper, is the distance from most anterior point in the frontal bone in the middle line to the most posterior point in the cranial vault on the horizontal plane in the middle line
Time frame: 4 weeks and 10 weeks
Cranial length
Measured with calliper, is the distance from most anterior point in the frontal bone in the middle line to the most posterior point in the cranial vault on the horizontal plane in the middle line
Time frame: 10 weeks
Cranial wide
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Time frame: 4 weeks
Cranial wide
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Time frame: 10 weeks
Cranial maximal circumference
Measured in cm with a measuring tape.
Time frame: 4 weeks
Cranial maximal circumference
Measured in cm with a measuring tape.
Time frame: 10 weeks
Alberta Infant Motor Scale
Neuromotor scale for infants from 0 to 14 months. Maximum value 90th; minimum value 0th. Higher scores indicate a better motor and postural development. Values below 15th indicate risk of development delay.
Time frame: 10 weeks
Visual Analogical Scale about improvement in cervical movement after intervention
Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the cervical movement.
Time frame: 10 weeks
Visual Analogical Scale about improvement in cranial asymmetry after intervention
Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the head shape
Time frame: 10 weeks
Plan to share: No
Started Jun 2019 (actual). Primary completion is estimated for May 2023, 47 months after the start.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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