Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000257369
Ethics application status
Approved
Date submitted
14/12/2016
Date registered
20/02/2017
Date last updated
31/05/2024
Date data sharing statement initially provided
31/05/2024
Date results information initially provided
31/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Influence of myofascial techniques on functional ability in patients with painful flat feet
Scientific title
The Influence of myofascial techniques on functional ability in patients with painful flat foot
Secondary ID [1] 290742 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
foot pain due to flat foot 301322 0
Condition category
Condition code
Musculoskeletal 301078 301078 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301476 301476 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Material
Study participants will be rectuited from Malopolska Voivodship. 60 patients will be randomized into 4 groups: 1- patients will undergo 4-weeks myofascial therapy twice a week and everyday exercise programme, 2- patients will undergo 4-weeks myofascial therapy twice a week, 3- patients will undergo 4-weeks everyday exercises programme , and 4- control group with no intervention.

Method
Myofascial therapy will last approximately 20 min and home exercise programme 20min. Myofascial release techniques use slow, sustained pressure, applied to restricted fascial layers to improve range of motion, decrease pain and restore function. Physiotherapist will use mainly separating of muscles compartments, anchor and stretch strokes and lifting or rolling muscle compartments These techniques will be apply on calf muscles, plantar fascia, peroneal muscles.

Home exercise programme will be based on the exercises which are usually recommended for foot problems e.g. calf stretching, “short foot”, long flexors of toes strengthening. Before beginning of programme, each participants will be instructed by physiotherapist and accuracy will be checked. Duration of this exercise programme should be approximately 20 min and patients will be asked to perform it twice a day during 4-weeks.
Intervention code [1] 296648 0
Rehabilitation
Intervention code [2] 297153 0
Treatment: Other
Comparator / control treatment
Control group will consist of 15 persons with painful flat foot. No intervention will be implement in this group only examination before and after 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300497 0
assessment of intensity of pain - by using VAS scale – ranged from 0 (no pain) to 10 (the worst possible)
Timepoint [1] 300497 0
baseline and end of treatment (4 weeks post baseline)
Primary outcome [2] 300868 0
Range of motion of ankle joint - active range of motion of plantar and dorsal flexion, inversion and eversion will be measured by goniometer
Timepoint [2] 300868 0
baseline and end of treatment (4 weeks post baseline)
Primary outcome [3] 300870 0
Dynamic plantar pressure – The measurements will be obtained with the use of FreeMed platform. Participants will walk in self-selected speed on the path which consists of passive panels (lengthen the path) and active panel (records data). During this plantar pressure will be collected, proceeded and analyzed.
Timepoint [3] 300870 0
baseline and end of treatment (4 weeks post baseline)
Secondary outcome [1] 330123 0
the standing tibiocalcaneal angle (STCA) – the angle between the bisection of the lower one third of the leg and the bisection of the calcaneus will be measured by goniometer in single-leg stance.
Timepoint [1] 330123 0
baseline and end of treatment (4 weeks post baseline)
Secondary outcome [2] 331077 0
navicular drop test - result of this test is a difference in navicular tuberosity height measured during bilateral and unilateral stance
Timepoint [2] 331077 0
baseline and end of treatment (4 weeks post baseline)
Secondary outcome [3] 331080 0
Foot and Ankle Outcomes Questionnaire FAOQ - it’s a tool to measure patient reported treatment outcomes in the ankle and foot. It contains 25 question and result ranges from 0 to 100 points. The less points the greater functional disability of limb.
Timepoint [3] 331080 0
baseline and end of treatment (4 weeks post baseline)

Eligibility
Key inclusion criteria
- flat foot ( Clark’s angle less than 31 degree)
- presence of foot pain
- No systemic contraindications to undertake the proposed forms of therapy
- Written consent to participate in a clinical trial
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- acute injury/ies that affected gait (less than 6 months)
- neurological, rheumatic, metabolic, orthopedic diseases

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2017
Actual
7/04/2017
Date of last participant enrolment
Anticipated
Actual
7/10/2019
Date of last data collection
Anticipated
Actual
4/11/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8501 0
Poland
State/province [1] 8501 0
Malopolska

Funding & Sponsors
Funding source category [1] 295172 0
Self funded/Unfunded
Name [1] 295172 0
Aneta Bac
Country [1] 295172 0
Poland
Primary sponsor type
Individual
Name
Aneta Bac
Address
Uniersity School of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 293998 0
None
Name [1] 293998 0
None
Address [1] 293998 0
None
Country [1] 293998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296521 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 296521 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 296521 0
Poland
Date submitted for ethics approval [1] 296521 0
10/05/2016
Approval date [1] 296521 0
14/06/2016
Ethics approval number [1] 296521 0
94/KBL/OIL/2016

Summary
Brief summary
The aim of this study is to evaluate efficiency of myofascial techniques in patients with painful flat foot/feet. Study participants will be rectuited from Kraków district. 60 patients will be randomized into 4 groups: 1- patients will undergo 4-weeks myofascial therapy twice a week and everyday exercise programme, 2- patients will undergo 4-weeks myofascial therapy twice a week, 3- patients will undergo 4-weeks everyday exercises programme , and 4- control group with no intervention. Myofascial therapy will last approximately 20 min and home exercise programme 20min. Before and after 4 weeks patients will undergo the following examinations: assessment of intensity of pain (VAS scale) and pain localization (authors scheme), visual alignment of pelvis, hips and knees, range of motion of ankle joint, the standing heel- rise test, the standing tibiocalcaneal angle (STCA), navicular drop test, FAOQ and dynamic plantar pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71150 0
A/Prof Aneta Bac
Address 71150 0
University School of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 71150 0
Poland
Phone 71150 0
+48126831065
Fax 71150 0
Email 71150 0
[email protected]
Contact person for public queries
Name 71151 0
A/Prof Aneta Bac
Address 71151 0
University School of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 71151 0
Poland
Phone 71151 0
+48126831065
Fax 71151 0
Email 71151 0
[email protected]
Contact person for scientific queries
Name 71152 0
A/Prof Aneta Bac
Address 71152 0
University School of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 71152 0
Poland
Phone 71152 0
+48126831065
Fax 71152 0
Email 71152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants consent to their personal data being processed by researchers of this project.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4038Plain language summaryNo Background/Introduction: Flat foot pain is a commo... [More Details]

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