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Trial registered on ANZCTR


Registration number
ACTRN12617000751370
Ethics application status
Approved
Date submitted
26/01/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative study of postural changes after global manipulation of the pelvis versus suboccipital inhibition in children aged 4 to 12 years affected by clubfoot: baropodometry and stabilometry
Scientific title
Comparative study of postural changes after global manipulation of the pelvis versus suboccipital inhibition in children aged 4 to 12 years affected by clubfoot: baropodometry and stabilometry
Secondary ID [1] 291011 0
None
Universal Trial Number (UTN)
U1111-1192-0805
Trial acronym
CPMGPVISPZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clubfoot 301787 0
Postural changes due to changes in the footprint, conditioned by the structural and functional limitations of the clubfoot 301788 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301479 301479 0 0
Physiotherapy
Musculoskeletal 302248 302248 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 302249 302249 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Global Manipulation of the pelvis bilaterally: opening the faces of L5 and sacroiliac joint. Patient in lateral decubitus, in lumbar roll possition. Rotation technique with contact in sacroiliac joint. 1 minute for each manipulation, total time for treatment 2 minutes. Patient will be lying in supine decubitus in the stretcher for 3 minutes. Total time included the time for the treatment are 5 minutes. Duration and frequency of treatment: treatment performed on one occasion only for 5 minutes (total time for treatment is 2 minutes, and lying time is 3 minutes)

Group 2: Suboccipital muscle inhibition. Patient lying face up (supine decubitus). therapist sitting with the distal part of the fingers in the suboccipital area, producing a slight ventral and craneal compression. The patient will be 5 minutes in supine decubitus while the treatment will be realized. Frequency and duration: treatment performed on one occasion only for 5 minutes ( total time for treatment and lying time is 5 minutes). In this case the treatment has a duration of 5 minutes, and at the same time, the patient is lying face up.

group 3 : Hands Mobilisation. Patient in supine decubitus, therapist sitting by his side. Articulatiry technique for both hands ( two minutes each one). The patient will be 5 minutes in supine decubitus while the therapist realiza the treatment. Frequency and duration: treatment performed on one occasion only for 5 minutes ( 4 minutes lying and treatment and 1 minute just lying face up)

Stabilometric and baropodometric measurements pre and post intervention.

All the treatment will be administered in a private traumatology clinic, in a room adapted to the physiotherapeutic care of patients, with a stretcher to perform the treatment and a timer to mark the intervention times. The data collection will be performed in a separate room suitable for it.

The treatments will be performed by an osteopath with more than 5 years of clinical experience in the field of pediatric osteopathy.
Intervention code [1] 296978 0
Rehabilitation
Comparator / control treatment
Group 3 Or Control Group: hands mobilisation.
Patient in supine decubitus.
Therapist sitting by his side.
Articulatiry technique for both hands ( two minutes each one).
The patient will be 5 minutes in supine decubitus ( 4 minutes lying and having treatment, and 1 minute just lying face up).
Control group
Active

Outcomes
Primary outcome [1] 300871 0
Baropodometric measurements assessed by a pressure platform: podoprint (Namrol) with auto calibration mode.:
1- Surface of right and left forefoot and hindfoot support and load percentage of right and left forefoot and hindfoot.


Timepoint [1] 300871 0
Before and after the intervention.
Primary outcome [2] 301654 0
Ratio forefoot and hindfoot with respect to the right and left foot. Meassurement with Podoprint (namrol) pressure platform.
Timepoint [2] 301654 0
before and after the intervention
Primary outcome [3] 302000 0
Total support surface, percentage of total load and total weight of the right and left foot. Meassurement with Podoprint (namrol) pressure platform.
Timepoint [3] 302000 0
before and after treatment.
Secondary outcome [1] 333470 0
Baropodometry : Measurement with (foot pressure) platform: podoprint (namrol company):

Maximum and mean support pressure, and location of maximum pressure point.
Timepoint [1] 333470 0
before and after treatment
Secondary outcome [2] 334496 0
X and Y coordinates of oscillation, and X and Y oscillation mean. Meassurement with Podoprint (namrol) pressure platform.
Timepoint [2] 334496 0
pre and post treatment
Secondary outcome [3] 334497 0
Velocity af anteroposterior and lateral displacement, and mean velocity of lateral displacement.Meassurement with Podoprint (namrol) pressure platform.
Timepoint [3] 334497 0
pre and post treatment.

Eligibility
Key inclusion criteria
Uni or bilateral clubfoot treated with Ponseti's method.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Syndromic or neurological clubfoot.
Physiotherapic or Osteopathic treatment in the last month.
Traumatologic Pathologies in lower extremities or spine in the last month.
Pathologies that present with balance alterations in the last month.
General Contraindications of the techniques (fractures, severa pathologies, etc...)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered folders
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned to a folder according to the order of arrival. I.e.: first arrival carpet 1, second arrival carpet 2, third arrival carpet 3. forth arrival carpet 1, fifth arrival carpet 2, etc...
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
69 patients divided 3 grupos of 23
Statistical analysis performed by a statistician external to the study group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/05/2017
Actual
Date of last participant enrolment
Anticipated
9/06/2017
Actual
Date of last data collection
Anticipated
19/06/2017
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment outside Australia
Country [1] 8606 0
Spain
State/province [1] 8606 0
Barcelona

Funding & Sponsors
Funding source category [1] 295440 0
Self funded/Unfunded
Name [1] 295440 0
Sandra Balaguer
Country [1] 295440 0
Spain
Primary sponsor type
Individual
Name
Sandra Balaguer
Address
Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy
c/ Ramon mONTENEGRO 32 BAJO 1
27002 Lugo

Spain
Country
Spain
Secondary sponsor category [1] 294259 0
None
Name [1] 294259 0
Address [1] 294259 0
Country [1] 294259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296771 0
S.E.F.O.: Scientific European Federation Osteopaths
Ethics committee address [1] 296771 0
Ethics committee country [1] 296771 0
Spain
Date submitted for ethics approval [1] 296771 0
Approval date [1] 296771 0
18/01/2017
Ethics approval number [1] 296771 0

Summary
Brief summary
The clubfoot (PEVAC) is a development patology, in the anatomopathological study of fetus affected with clubfoot it has been shown that the ligamento Deltoideus, scaphoid-talus and the posterior tibial tendón are very thickened and attached to the calcareis scaphoid plantar ligament. The clubfoot is considered a multifactorial inheritance.

The Ponseti method is based on the ability of elongation of collagen fibers present in the pathological ligaments of children with clubfoot, as well as taking into account the biology of the deformity. Dr Ponseti gives special importance to the correction based in the funcional anatomy of the foot

The prevalece of this pathology, the serious functional consequences that causes its absence of treatment or incorrect treatment, and the socio-health cost that the management of this type of patient means, makes that this pathology generates special interest.

Once the corrective treatment of the deformity is completed and the correction is stabilized, it is considered that the child can perform recurrences of the disease until the age of 3-4 years.

Nowadays there is an increasing awareness of the importance of posture in the development of children. In the clubfoot case join the modification of the plantar supports, the load distribution and the size of the affected foot-leg, modifies the position and development of this.

There are previous studies that relate baropodometric and stabilometric modificaciones after the global manipulation of the pelvis in healthy subjects, and changes in the extensibility of hamstrings with the same manipulation. Aswell we have found studies that relate the suboccipital inhibition technicque with postural measurements modification, and changes of the extensibility of hamstrings in persons with shortness hamstrings syndrom.

In this study we want to evaluate the differences in the plantar supports and in the distribution of load after an global manipulation of the pelvis or after an inhibition of sub occipital musculature.

For this we will divide the participants in this study in three groups:

First group: Global manipulation of the pelvis. We will seek to improve the mobility of the pelvis.
Second group: inhibition of sub occipital musculature. In this case the objective will be to relax the musculature in the cranium-cervical joint.
Third group: articular mobilization of the hands. Is the placebo group.

The treatment will be performed on one occasion only for 5 minutes.

Before and after the treatment we will record the stabilometric and baropodometric data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72006 0
Ms Sandra Balaguer Sole
Address 72006 0
Sandra Balaguer Sole
Centro Munoz Balaguer osteopathy and phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain
Country 72006 0
Spain
Phone 72006 0
+34679050735
Fax 72006 0
Email 72006 0
[email protected]
Contact person for public queries
Name 72007 0
Sandra Balaguer
Address 72007 0
Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and physiotherapy
c/Ramon Montenegro 32 bajo 1
27002 Lugo
Spain
Country 72007 0
Spain
Phone 72007 0
+34679050735
Fax 72007 0
Email 72007 0
[email protected]
Contact person for scientific queries
Name 72008 0
sandra balaguer
Address 72008 0
Sandra Balaguer sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain
Country 72008 0
Spain
Phone 72008 0
+34679050735
Fax 72008 0
Email 72008 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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