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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]

None

Universal Trial Number (UTN)

U1111-1192-0805

Trial acronym

CPMGPVISPZ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Clubfoot

Postural changes due to changes in the footprint, conditioned by the structural and functional limitations of the clubfoot

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Human Genetics and Inherited Disorders

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]

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]

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]

Before and after the intervention.

Primary outcome [2]

Ratio forefoot and hindfoot with respect to the right and left foot. Meassurement with Podoprint (namrol) pressure platform.

Timepoint [2]

before and after the intervention

Primary outcome [3]

Total support surface, percentage of total load and total weight of the right and left foot. Meassurement with Podoprint (namrol) pressure platform.

Timepoint [3]

before and after treatment.

Secondary outcome [1]

Baropodometry : Measurement with (foot pressure) platform: podoprint (namrol company):

Maximum and mean support pressure, and location of maximum pressure point.

Timepoint [1]

before and after treatment

Secondary outcome [2]

X and Y coordinates of oscillation, and X and Y oscillation mean. Meassurement with Podoprint (namrol) pressure platform.

Timepoint [2]

pre and post treatment

Secondary outcome [3]

Velocity af anteroposterior and lateral displacement, and mean velocity of lateral displacement.Meassurement with Podoprint (namrol) pressure platform.

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Barcelona

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Sandra Balaguer

Address [1]

Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy (Osteopatia y Fisioterapia)
c/ Ramon montenegro 32 bajo 1
27002 Lugo
Spain

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

S.E.F.O.: Scientific European Federation Osteopaths

Ethics committee address [1]

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

18/01/2017

Ethics approval number [1]

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

Ms Sandra Balaguer Sole

Address

Sandra Balaguer Sole
Centro Munoz Balaguer osteopathy and phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain

Country

Spain

Phone

+34679050735

Fax

sbalaguer@centromunozbalaguer.com

Contact person for public queries

Name

Sandra Balaguer

Address

Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and physiotherapy
c/Ramon Montenegro 32 bajo 1
27002 Lugo
Spain

Country

Spain

Phone

+34679050735

Fax

sbalaguer@centromunozbalaguer.com

Contact person for scientific queries

Name

sandra balaguer

Address

Sandra Balaguer sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain

Country

Spain

Phone

+34679050735

Fax

sbalaguer@centromunozbalaguer.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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