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Trial registered on ANZCTR


Registration number
ACTRN12621000902897
Ethics application status
Approved
Date submitted
15/05/2020
Date registered
12/07/2021
Date last updated
7/09/2022
Date data sharing statement initially provided
12/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of conservative treatment using Kinesiology Taping, orthosis and exercise in women with hallux valgus.
Scientific title
The impact of conservative treatment using Kinesiology Taping, orthosis and exercise in women with hallux valgus.
Secondary ID [1] 300403 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hallux valgus 316063 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314333 314333 0 0
Physiotherapy
Physical Medicine / Rehabilitation 314334 314334 0 0
Other physical medicine / rehabilitation
Musculoskeletal 317976 317976 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research material consisted of 113 women aged 38 to 58 years. The study group included women with mild to moderate hallux valgus deformity (57 people), and the control groups were women with correctly shaped feet (31 people) and women with hallux valgus without any physiotherapeutic interactions (25 people). Women with mild to moderate hallux valgus deformities were qualified to participate in the study according to the Manchester scale. Each of the surveyed women was informed in detail about the course of the research and asked for a written consent to participate in the project.
Patients from the study group were randomly assigned to one of three groups:
EKT group I (exercises, Kinesiology Taping) 18 people: women who participated in the exercise program for 12 weeks and additionally had the Kinesio Taping application for the hallux valgus every 4 days (exercises twice a week with a physiotherapist and on the other days the patient exercised independently in home, changing the application of Kinesio Taping every 4 days, exercise duration 45 minutes). The tapes in each of the patients from the EKT group (exercises, Kinesiology Taping) were changed every 4 days for 12 weeks. The first application was made immediately after the first exercises with the therapist. The tapes were applied by the same physiotherapist.
Applications in hallux valgus:
• Application with the fascial technique (15-25%) in the Y-form. The base was glued to the toe, tails along the medial edge of the foot
• The technique of fascial correction in form I was then performed. The base was glued to the medial-dorsal surface of the forefoot, the tail was guided towards the outer dorsal surface of the foot. While sticking the tape, the foot is bent
• In addition, if the big toe has been rotated prior to the procedure from point 1, an application was made to correct the position of the big toe

ENS group II (exercise, night splints "Marcin") 15 people: women who participated in the exercise program for 12 weeks and additionally used the Marcin correction apparatus at night for 12 weeks (exercises with a physiotherapist twice a week, on the other days the patient she practiced alone at home, put on a corrective device "Marcin" for the night, exercise time 45 minutes). Each of the women qualified for the CAK group (exercises, corrective apparatus) received the "Marcin" kit on the day of starting the 12-week exercise program. The set included two "Marcin" corrective braces: on the right and left big toe. Each of the apparatuses consisted of: a plastic part lined with foam, a leather band and a tightening strap allowing for the regulation of the pulling forces. The women were informed about how to put the splint on and were asked to put on the braces every day at night, paying attention that the tension of the Velcro did not cause pain. As the big toe adapted to the apparatus used, the women were able to increase their stretching force.

Group E (exercises) 24 people: women who participated in the exercise program for 12 weeks (exercises with a physiotherapist twice a week, on the remaining days the patient exercised alone at home, exercise time 45 minutes).
The therapeutic program for women from the EKT, ENS, E groups lasted 12 weeks. Women exercised twice a week under the supervision of a physiotherapist. Duration of exercise - 45 minutes. The exercise program included: gastrocnemius and soleus stretching exercises; exercises to activate the short muscles of the foot, balance exercises, sensorimotor exercises, exercises to load the foot properly, elements of self-relaxation, and general rehabilitation exercises
On the remaining days of the week, women from the EKT, ENS and E groups performed five exercises recommended by the physiotherapist (1st ball rolling of the plantar part of the foot - time 1 min, 2nd traction in the metatarsophalangeal joint - 5 times, 3rd passive correction of the position of the big toe - 15 times, 4, 5 exercises to activate the deep foot - "short foot", "spreading the toe" - 15 times).

During the first meeting, the subjects of the EKT and ENS groups as well as the E groups received a set of five exercises to perform daily at home. They also received a diary, in which they were to mark the regularity of exercise with an "x". During each class with a physiotherapist, the subjects were asked about the regularity of exercising at home. Additionally, all the exercises commissioned for independent performance were discussed, analyzed and recorded. During the last class, participants handed over completed diaries. The regularity of doing home exercises ranged between 60% -95%.
Intervention code [1] 316708 0
Rehabilitation
Comparator / control treatment
The control group consisted of two groups of women:
First control group CTN (control, normal toe) 31 people: women with a correctly positioned big finger (toe) /women without hallux valgus/
Second control group CHV (control, hallux valgus) 25 people: women with mild to moderate hallux valgus not exposed to any effects.
Control group
Active

Outcomes
Primary outcome [1] 322886 0
Assessment of which of the methods used (Kinesiology Taping + exercise; night splints + exercise or just exercise) brings the best results in terms of improving the position of the big toe?

The big toe position was assessed:
Big toe position measured using a computer podoscope and
Grade of hallux valgus, as measured using the Manchester scale.
Timepoint [1] 322886 0
at the beginning and immediately after completion of your 12-week exercise program
Primary outcome [2] 326006 0
Which of the methods used (Kinesiology Taping + exercise; night splints + exercise or just exercise) is more effective in reducing pain intensity?

Pain, as measured by Visual Analog Scale
Timepoint [2] 326006 0
at the beginning and immediately after completion of your 12-week exercise program
Primary outcome [3] 326007 0
Which of the methods used (Kinesiology Taping + exercise; night splints + exercise or just exercise) gives better results in improving the balance?


The static equilibrium test was conducted twice on the BTS P-walk baroresistive platform (eyes open, eyes closed)
Timepoint [3] 326007 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [1] 380143 0
Assessment of the range of motion in the ankle joint, in the metatarsophalangeal joint and in the interphalangeal joint of the big toe.

A goniometer was used to assess the range of motion in the joints.
Timepoint [1] 380143 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [2] 380144 0
Assessment of selected foot indexes - Wejsflog index

A computer podoscope was used to assess selected indicators in the area of the feet
Timepoint [2] 380144 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [3] 380145 0
Assessment of the load on selected plantar zones of the right and left foot.

The BTS P-Walk baroresistive platform was used to assess the load on the selected zones of the right and left feet.
Timepoint [3] 380145 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [4] 380146 0
Assessment of flexibility of the gastrocnemius muscles.

The muscle flexibility was assessed by a physiotherapist.
Timepoint [4] 380146 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [5] 398094 0
Assessment of selected foot indexes - Clarke's angle

A computer podoscope was used to assess selected indicators in the area of the feet
Timepoint [5] 398094 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [6] 398095 0
Assessment of selected foot indexes - hallux valgus angle and V toe varus angle).
Timepoint [6] 398095 0
at the beginning and immediately after completion of your 12-week exercise program
Secondary outcome [7] 398096 0
Assessment of flexibility of the soleus muscles.

The muscle flexibility was assessed by a physiotherapist.
Timepoint [7] 398096 0
at the beginning and immediately after completion of your 12-week exercise program

Eligibility
Key inclusion criteria
- female gender
- consent to participate in the program,
- presence of mild to moderate deformity of hallux valgus according to Manchester scale
Minimum age
38 Years
Maximum age
58 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- condition after hallux valgus surgery
- diabetes
- gout,
- neurological diseases,
- rheumatoid arthritis,
- ankylosing spondylitis,
- fresh injury (up to 2 months) in the lower limbs and pelvis,
- advanced flat feet,
- excessive pronation of the foot.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the correlation coefficient of chosen variables two statistical test will be used – Chi square (x2) and t-Student. For all compared variables the level of relevancywill set at alpha=0,05 (p<0,05). The correlation coefficient with probability of p<0,01 will be recognized as highly relevant, and correlation coefficient with probability of p<0,001 will be recognized as extremely relevant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/09/2016
Date of last participant enrolment
Anticipated
Actual
31/05/2017
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
150
Accrual to date
Final
113
Recruitment outside Australia
Country [1] 22538 0
Poland
State/province [1] 22538 0
Tarnow

Funding & Sponsors
Funding source category [1] 304827 0
University
Name [1] 304827 0
University of Applied Sciences
Country [1] 304827 0
Poland
Primary sponsor type
University
Name
University of Applied Sciences
Address
University of Applied Sciences
ul. Mickiewicza 8
33-100 Tarnów, Poland
Country
Poland
Secondary sponsor category [1] 305158 0
None
Name [1] 305158 0
Address [1] 305158 0
Country [1] 305158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305238 0
Regional Medical Chamber in Tarnów
Ethics committee address [1] 305238 0
Ethics committee country [1] 305238 0
Poland
Date submitted for ethics approval [1] 305238 0
25/01/2016
Approval date [1] 305238 0
31/03/2016
Ethics approval number [1] 305238 0
4/0177/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99722 0
Dr Katarzyna Wodka
Address 99722 0
University of Applied Sciences in Tarnow
ul. Mickiewicza 8
33-100 Tarnow
Country 99722 0
Poland
Phone 99722 0
+48 781 057 385
Fax 99722 0
Email 99722 0
k_wodka@pwsztar.edu.pl
Contact person for public queries
Name 99723 0
Katarzyna Wodka
Address 99723 0
University of Applied Sciences in Tarnow
ul. Mickiewicza 8
33-100 Tarnow
Country 99723 0
Poland
Phone 99723 0
+48 781 057 385
Fax 99723 0
Email 99723 0
k_wodka@pwsztar.edu.pl
Contact person for scientific queries
Name 99724 0
Katarzyna Wodka
Address 99724 0
University of Applied Sciences in Tarnow
ul. Mickiewicza 8
33-100 Tarnow
Country 99724 0
Poland
Phone 99724 0
+48 781 057 385
Fax 99724 0
Email 99724 0
k_wodka@pwsztar.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7949Ethical approval  k_wodka@pwsztar.edu.pl All date are available from the authors and may be... [More Details]
7950Informed consent form  k_wodka@pwsztar.edu.pl All date are available from the authors and may be... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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