Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000387527
Ethics application status
Approved
Date submitted
21/01/2015
Date registered
28/04/2015
Date last updated
28/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation stretching technique for high arch foot radiological angle changes
Scientific title
Changes in the Internal Moreau-Costa-Bertani, the first metatarsal declination and calcaneal pitch angles before, immediately after, and one week after administering the neuromuscular stretching technique to people with pes cavus.
Secondary ID [1] 286033 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cavus foot 294003 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294302 294302 0 0
Physiotherapy
Musculoskeletal 294303 294303 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First we diagnosed pes cavus from a -bearing lateral radiography of both feet. The radiological angles were measured using the AutoCad'Registered Trademark'(AutoCad 2007) software package.
The electrotherapy instrument used to provoke the stretching of the fascia and of the intrinsic muscles of the foot was the TENS MED 931'Registered Trademark'(Enraf-Nonius, Rotterdam, Netherlands). The neuromuscular stretching was carried out on the subject's dominant foot. The contralateral foot was the control. To stretch the fascia and intrinsic muscles through electrical stimulation, the stimulating electrodes were put in place and the subject stood on one leg, holding on to a bar to keep steady. The current intensity was increased until we observed contraction of the toes (besides, the current intensity depends on the threshold of tolerance of each subject) At that point we stopped increasing the current. When relaxation of the toes was evident to the examiner, the intensity of the current was again increased until there was another toe contraction. This procedure was repeated thrice as is established for post-isometric muscle relaxation procedures. The duration of the stretching varied from subject to subject, but ranged from 2 to 5 minutes.
Post-intervention radiographic measurements were performed immediately after the completion of the neuromuscular technique, following the protocol described above. To evaluate the short-term effects, these measurements were repeated one week after the intervention.
Intervention code [1] 291443 0
Treatment: Devices
Intervention code [2] 291444 0
Rehabilitation
Comparator / control treatment
Non dominan foot of subject was control group. In this foot, the neuromuscular stretching technique was not performed
Control group
Active

Outcomes
Primary outcome [1] 294591 0
-Internal Moreau-Costa-Bertani angle.
To measure this angle, three points are marked:
(1) the lowest point of the posterior calcaneal tuberosity;
(2) the lowest point of the talar head;
and (3) the plantarmost surface of the internal sesamoid.

The two lines formed by joining points 1 and 2 and points 2 and 3 give the final angle as a result.
Timepoint [1] 294591 0
This angle was measured three times:
- Before the intervention technique (stretching)
-Immediately after stretching
-Second timepoint (one week after stretching)
Primary outcome [2] 294592 0
-Calcaneal pitch angle.

This angle results from the intersection of the line tangent to the plantar surface of the calcaneus with the line parallel to the horizontal of the ground.
Timepoint [2] 294592 0
This angle was measured three times:
- Before the intervention technique (stretching)
-Immediately after stretching
-Second timepoint( one week after stretching)
Primary outcome [3] 294593 0
-First metatarsal declination angle.

This angle results from the intersection between the axis of the first metatarsal shaft and the horizontal.
Timepoint [3] 294593 0
This angle was measured three times:
- Before the intervention technique (stretching)
-Immediately after stretching
-Second timepoint( one week after stretching)
Secondary outcome [1] 313710 0
Nil
Timepoint [1] 313710 0
Nil

Eligibility
Key inclusion criteria
(I) having pes cavus. For this criterion, a weight-bearing lateral radiograph was taken of the dominant foot, measuring the Internal Moreau-Costa-Bertani angle, with pes cavus corresponding to a value greater than 125 degrees.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(I)having a degenerative musculoskeletal, tumoral, or systemic disease
(II)having undergone foot surgery
III)having received manual foot treatment of some sort in the four weeks prior to the study
(IV)using orthopodiatric treatment for pes cavus
(V)having had serious trauma to the foot.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non dominan foot was control group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The required sample size was calculated assuming a one-tailed hypothesis (subjects in both groups were expected to improve), a between-group allocation ratio of 1:1, a medium effect size (d=0.55), an alpha value of 0.05, and a power of 90% (Gpower 3.1.2´Registered Trademark´ Kiel University, Germany). Thirty subjects were necessary to complete the study. Given that some subjects might be lost through abandoning the study (although actually there were ultimately zero losses), we included 34 subjects in the study.

Data analysis was performed using the statistical software package SPSS 18.0 for Windows (SPSS Inc., Chicago, Illinois). A repeated measures analysis of variance (ANOVA) was performed to analyse the intra-subject factor for the three times of measurement and the paired-groups comparison. To determine the relationship between the three radiological angles measured, we used the Pearson correlation coefficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2013
Actual
10/03/2013
Date of last participant enrolment
Anticipated
15/01/2014
Actual
20/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 6607 0
Spain
State/province [1] 6607 0
Seville

Funding & Sponsors
Funding source category [1] 290624 0
University
Name [1] 290624 0
University of Sevilla (Spain)
Country [1] 290624 0
Spain
Primary sponsor type
University
Name
University of Sevilla (Spain)
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 289314 0
None
Name [1] 289314 0
Address [1] 289314 0
Country [1] 289314 0
Secondary sponsor category [2] 289315 0
Individual
Name [2] 289315 0
Lourdes Maria Fernandez-Seguin
Address [2] 289315 0
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/Avicena s/n 41009 Sevilla (Spain)
Country [2] 289315 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292253 0
COMITE ETICO DE EXPERIMENTACION DE LA UNIVERSIDAD DE SEVILLA
Ethics committee address [1] 292253 0
Ethics committee country [1] 292253 0
Spain
Date submitted for ethics approval [1] 292253 0
Approval date [1] 292253 0
17/02/2008
Ethics approval number [1] 292253 0
NONE

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 396 396 0 0
/AnzctrAttachments/367818-JAPMA 2013 LOU.pdf

Contacts
Principal investigator
Name 54330 0
Prof Lourdes Maria Fernandez Seguin
Address 54330 0
Department of Physiotherapy
Faculty of Nursing, Physitherapy and Podiatry
C/ Avicena s/n 41009 Sevilla (Spain)
Country 54330 0
Spain
Phone 54330 0
+34 954486505
Fax 54330 0
Email 54330 0
[email protected]
Contact person for public queries
Name 54331 0
Lourdes Maria Fernandez Seguin
Address 54331 0
Department of Physiotherapy
Faculty of Nursing, Physitherapy and Podiatry
C/ Avicena s/n 41009 Sevilla (Spain)
Country 54331 0
Spain
Phone 54331 0
+34 954486505
Fax 54331 0
Email 54331 0
[email protected]
Contact person for scientific queries
Name 54332 0
Lourdes Maria Fernandez Seguin
Address 54332 0
Department of Physiotherapy
Faculty of Nursing, Physitherapy and Podiatry
C/ Avicena s/n 41009 Sevilla (Spain)
Country 54332 0
Spain
Phone 54332 0
+34 954486505
Fax 54332 0
Email 54332 0
[email protected]

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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