ANZCTR - Registration

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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

Date results information 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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Hallux valgus

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

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]

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]