Plagiocephaly, NonsynostoticNCT04672837
Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
A study testing Pediatric Integrative Manual Therapy and educational therapy and Stretching and educational therapy in people with Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis
- What is being tested?
- Pediatric Integrative Manual Therapy and educational therapy and Stretching and educational therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sign of positional plagiocephaly
- Infants below 12 moths age
Who cannot join
- No neurological disorders
- No infectious diseases
- No respiratory diseases
- No other treatments
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto deTerapias Integrativas
Zaragoza, 50001
Iñaki Pastor Pons, +34657272757, inakipas@gmail.com
Elena Lecha, +34 976284470, elena@itifisioterapia.com
About this study
Official title: Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
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
Read the detailed description
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.
- Being tested
- Pediatric Integrative Manual Therapy and educational therapy, Stretching and educational therapy
- Keywords
- Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head
- Medical subject headings
- Plagiocephaly, Nonsynostotic, Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Integrative Manual Therapy and educational therapyProcedure or surgery
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.
Stretching and educational therapyProcedure or surgery
It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | 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. Receives: Procedure: Pediatric Integrative Manual Therapy and educational therapy |
| Stretching Group | Active comparator | 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. Receives: Procedure: Stretching and educational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 weeks
Active Cervical Rotation Range of movement
Measured with photographs and digital angular analysis
Measured: 4 weeks
Active Cervical Rotation Range of movement
Measured with digital angular analysis
Measured: 10 weeks
Passive Cervical Rotation Range of movement
Measured lying down with joint goniometer
Measured: 4 weeks
Passive Cervical Rotation Range of movement
Measured lying down with joint goniometer
Measured: 10 weeks
Passive Cervical Lateral Flexion Range of movement
Measured lying down with joint goniometer
Measured: 4 weeks
Passive Cervical Lateral Flexion Range of movement
Measured lying down with joint goniometer
Measured: 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
Measured: 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
Measured: 10 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 10 weeks
Cranial maximal circumference
Measured in cm with a measuring tape.
Measured: 4 weeks
Cranial maximal circumference
Measured in cm with a measuring tape.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2019
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Plagiocephaly, NonsynostoticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iñaki Pastor Pons, Universidad de Zaragoza
- Investigators
- Orosia Lucha, Study chair, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672837
- Sponsor's protocol ID
- PMT2
- Status last verified
- May 2022
- First submitted
- 2 Dec 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Billi M, Greco A, Colonneli P, Volpi G, Valente D, Galeoto G. The functional manual therapy intervention in infants with non-synostotic plagiocephaly: a pilot study. Minerva Pediatr (Torino). 2022 Jun;74(3):294-300. doi: 10.23736/S2724-5276.17.04838-1. Epub 2017 Oct 25.
PubMed 29072040Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benitez-Feliponi A, Robles-Vizcaino C, Ruiz-Extremera A. Effects of manual therapy on treatment duration and motor development in infants with severe nonsynostotic plagiocephaly: a randomised controlled pilot study. Childs Nerv Syst. 2016 Nov;32(11):2211-2217. doi: 10.1007/s00381-016-3200-5. Epub 2016 Jul 27.
PubMed 27465676Bagagiolo D, Didio A, Sbarbaro M, Priolo CG, Borro T, Farina D. Osteopathic Manipulative Treatment in Pediatric and Neonatal Patients and Disorders: Clinical Considerations and Updated Review of the Existing Literature. Am J Perinatol. 2016 Sep;33(11):1050-4. doi: 10.1055/s-0036-1586113. Epub 2016 Sep 7.
PubMed 27603533Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
PubMed 30030600Williams E. Preventing "Flat-headed" Babies: A Commentary on "Impact of Parent Practices of Infant Positioning on Head Orientation Profile and Development of Positional Plagiocephaly in Healthy Term Infants". Phys Occup Ther Pediatr. 2018 Feb;38(1):15-17. doi: 10.1080/01942638.2018.1405661. No abstract available.
PubMed 29372872Nahles S, Klein M, Yacoub A, Neyer J. Evaluation of positional plagiocephaly: Conventional anthropometric measurement versus laser scanning method. J Craniomaxillofac Surg. 2018 Jan;46(1):11-21. doi: 10.1016/j.jcms.2017.10.010. Epub 2017 Oct 16.
PubMed 29137851van Vlimmeren LA, Engelbert RH, Pelsma M, Groenewoud HM, Boere-Boonekamp MM, der Sanden MW. The course of skull deformation from birth to 5 years of age: a prospective cohort study. Eur J Pediatr. 2017 Jan;176(1):11-21. doi: 10.1007/s00431-016-2800-0. Epub 2016 Nov 4.
PubMed 27815732Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial. Eur J Pediatr. 2015 Sep;174(9):1197-208. doi: 10.1007/s00431-015-2520-x. Epub 2015 Apr 1.
PubMed 25823758De Bock F, Braun V, Renz-Polster H. Deformational plagiocephaly in normal infants: a systematic review of causes and hypotheses. Arch Dis Child. 2017 Jun;102(6):535-542. doi: 10.1136/archdischild-2016-312018. Epub 2017 Jan 19.
PubMed 28104626Ohman A, Mardbrink EL, Stensby J, Beckung E. Evaluation of treatment strategies for muscle function in infants with congenital muscular torticollis. Physiother Theory Pract. 2011 Oct;27(7):463-70. doi: 10.3109/09593985.2010.536305. Epub 2011 May 15.
PubMed 21568831Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.
PubMed 21145518Ohman AM, Nilsson S, Beckung ER. Validity and reliability of the muscle function scale, aimed to assess the lateral flexors of the neck in infants. Physiother Theory Pract. 2009 Feb;25(2):129-37. doi: 10.1080/09593980802686904.
PubMed 19212900Di Chiara A, La Rosa E, Ramieri V, Vellone V, Cascone P. Treatment of Deformational Plagiocephaly With Physiotherapy. J Craniofac Surg. 2019 Oct;30(7):2008-2013. doi: 10.1097/SCS.0000000000005665.
PubMed 31232996Systematic Review and Evidence-Based Guidelines for the Management of Patients with Positional Plagiocephaly. Pediatrics. 2016 Nov;138(5):e20162802. doi: 10.1542/peds.2016-2802. No abstract available.
PubMed 27940801
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
- ClinicalTrials.gov ID
- NCT04672837
- Acronym / sponsor ID
- PMT2
- Keywords
- Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Procedure: Pediatric Integrative Manual Therapy and educational therapy10 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. |
| Stretching Group | Active comparator | Procedure: Stretching and educational therapyA 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. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Sign of positional plagiocephaly
- Infants below 12 moths age
Key exclusion criteria (4 listed)
- No neurological disorders
- No infectious diseases
- No respiratory diseases
- No other treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Integrative Manual Therapy and educational therapyPediatric 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. | Procedure or surgery | Manual Therapy Group |
| Stretching and educational therapyIt is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc. | Procedure or surgery | Stretching Group |
Primary outcome
Right Oblique Cranial Vault Diameter
Time frame: 4 weeks
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Right Oblique Cranial Vault Diameter
Time frame: 10 weeks
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Left Oblique Cranial Vault Diameter
Time frame: 4 weeks
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Left Oblique Cranial Vault Diameter
Time frame: 10 weeks
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Active Cervical Rotation Range of movement
Time frame: 4 weeks
Measured with photographs and digital angular analysis
Active Cervical Rotation Range of movement
Time frame: 10 weeks
Measured with digital angular analysis
Passive Cervical Rotation Range of movement
Time frame: 4 weeks
Measured lying down with joint goniometer
Passive Cervical Rotation Range of movement
Time frame: 10 weeks
Measured lying down with joint goniometer
Passive Cervical Lateral Flexion Range of movement
Time frame: 4 weeks
Measured lying down with joint goniometer
Passive Cervical Lateral Flexion Range of movement
Time frame: 10 weeks
Measured lying down with joint goniometer
Muscle Function Test
Time frame: 4 weeks
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Muscle Function Test
Time frame: 10 weeks
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
9 secondary outcomes
Cranial length
Time frame: 4 weeks and 10 weeks
Cranial length
Time frame: 10 weeks
Cranial wide
Time frame: 4 weeks
Cranial wide
Time frame: 10 weeks
Cranial maximal circumference
Time frame: 4 weeks
Cranial maximal circumference
Time frame: 10 weeks
Alberta Infant Motor Scale
Time frame: 10 weeks
Visual Analogical Scale about improvement in cervical movement after intervention
Time frame: 10 weeks
Visual Analogical Scale about improvement in cranial asymmetry after intervention
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 29072040Billi M, Greco A, Colonneli P, Volpi G, Valente D, Galeoto G. The functional manual therapy intervention in infants with non-synostotic plagiocephaly: a pilot study. Minerva Pediatr (Torino). 2022 Jun;74(3):294-300. doi: 10.23736/S2724-5276.17.04838-1. Epub 2017 Oct 25.
- Background: PubMed 27465676Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benitez-Feliponi A, Robles-Vizcaino C, Ruiz-Extremera A. Effects of manual therapy on treatment duration and motor development in infants with severe nonsynostotic plagiocephaly: a randomised controlled pilot study. Childs Nerv Syst. 2016 Nov;32(11):2211-2217. doi: 10.1007/s00381-016-3200-5. Epub 2016 Jul 27.
- Background: PubMed 27603533Bagagiolo D, Didio A, Sbarbaro M, Priolo CG, Borro T, Farina D. Osteopathic Manipulative Treatment in Pediatric and Neonatal Patients and Disorders: Clinical Considerations and Updated Review of the Existing Literature. Am J Perinatol. 2016 Sep;33(11):1050-4. doi: 10.1055/s-0036-1586113. Epub 2016 Sep 7.
- Background: PubMed 30030600Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
- Background: PubMed 29372872Williams E. Preventing "Flat-headed" Babies: A Commentary on "Impact of Parent Practices of Infant Positioning on Head Orientation Profile and Development of Positional Plagiocephaly in Healthy Term Infants". Phys Occup Ther Pediatr. 2018 Feb;38(1):15-17. doi: 10.1080/01942638.2018.1405661. No abstract available.
- Background: PubMed 29137851Nahles S, Klein M, Yacoub A, Neyer J. Evaluation of positional plagiocephaly: Conventional anthropometric measurement versus laser scanning method. J Craniomaxillofac Surg. 2018 Jan;46(1):11-21. doi: 10.1016/j.jcms.2017.10.010. Epub 2017 Oct 16.
- Background: PubMed 27815732van Vlimmeren LA, Engelbert RH, Pelsma M, Groenewoud HM, Boere-Boonekamp MM, der Sanden MW. The course of skull deformation from birth to 5 years of age: a prospective cohort study. Eur J Pediatr. 2017 Jan;176(1):11-21. doi: 10.1007/s00431-016-2800-0. Epub 2016 Nov 4.
- Background: PubMed 25823758Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial. Eur J Pediatr. 2015 Sep;174(9):1197-208. doi: 10.1007/s00431-015-2520-x. Epub 2015 Apr 1.
- Background: PubMed 28104626De Bock F, Braun V, Renz-Polster H. Deformational plagiocephaly in normal infants: a systematic review of causes and hypotheses. Arch Dis Child. 2017 Jun;102(6):535-542. doi: 10.1136/archdischild-2016-312018. Epub 2017 Jan 19.
- Background: PubMed 21568831Ohman A, Mardbrink EL, Stensby J, Beckung E. Evaluation of treatment strategies for muscle function in infants with congenital muscular torticollis. Physiother Theory Pract. 2011 Oct;27(7):463-70. doi: 10.3109/09593985.2010.536305. Epub 2011 May 15.
- Background: PubMed 21145518Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.
- Background: PubMed 19212900Ohman AM, Nilsson S, Beckung ER. Validity and reliability of the muscle function scale, aimed to assess the lateral flexors of the neck in infants. Physiother Theory Pract. 2009 Feb;25(2):129-37. doi: 10.1080/09593980802686904.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orosia Lucha study chair
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Integrative Manual Therapy and educational therapy and Stretching and educational therapy in people with Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iñaki Pastor Pons (+34657272757, inakipas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Oblique Cranial Vault Diameter (time frame: 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672837, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.