Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus
Primary Purpose
Exercise, Hallux Valgus
Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Stretching the intrinsic muscles
Thumb Abduction with MTF Joint Traction
Thumb active extension exercise
Toe spread out
Short foot
Heel rise
Towel toe curl
Gastrocnemius active static stretching exercise
Plantar fascia and gastrocnemius stretching exercise on step
Sponsored by
About this trial
This is an interventional treatment trial for Exercise focused on measuring hallux valgus, exercise, home program
Eligibility Criteria
Inclusion Criteria:
- Volunteer individuals between the ages of 18-64
- Mild to moderate (15-40 degrees) hallux valgus
- Bilateral hallux valgus
- Have not received physical therapy for hallux valgus in the last 6 months,
- Individuals who did not use orthotic devices or dynamic splints for the treatment of hallux valgus will be included in the study.
Exclusion Criteria:
- HVA ≥ 45°
- Rjjit hallux valgus deformity (in cases where the hallux cannot be brought to its normal position manually)
- Obesity (BMI>30 kg/m2)
- Systemic disease and inflammatory arthritis (rheumatoid arthritis, systemic lupus, diabetes mellitus)
- Neurological disease (eg: neuropathy)
- Vestibular disorder that may affect balance
- History of standing trauma, fracture of the metatarophalangeal joint,
- He has undergone foot-ankle surgery,
- Using NSAIDs or analgesics
Sites / Locations
- Merve Betül ÖztarsuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
exercise with a physiotherapist
home program
Arm Description
Participants will exercise with a physiotherapist. 4 times a week for 8 weeks
The same exercises will be given to the participants as brochures. 4 times a week for 8 weeks
Outcomes
Primary Outcome Measures
hallux valgus angle
The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.
Secondary Outcome Measures
hallux valgus pain
Hallux valgus pain will be measured with the VAS scale at the beginning and end of treatment.
Functional Status
Static Balance Evaluation: It will be evaluated with the one-leg standing test.Dynamic Balance Evaluation: It will be evaluated by Y balance test.Functional capacity: To be evaluated with a 6-minute walk test.Foot Function Index (FFI): This index measures pain, function and activity limitation
life quality
The SF-36 quality of life questionnaire will be used to assess general health-related quality of life.
kinesiophobia
The Tampa Kinesiophobia Scale will be used to measure the fear of movement or re-injury.
Full Information
NCT ID
NCT05000398
First Posted
August 8, 2021
Last Updated
August 8, 2021
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT05000398
Brief Title
Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus
Official Title
Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
August 16, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study is to compare the effects of progressive exercise therapy, administered as a home program under the supervision of a physiotherapist, on adduction angle, pain, functional status, quality of life, and kinesiophobia in individuals aged 18-64 years with a hallux valgus angle of 15-40 degrees (mild-moderate).
Detailed Description
According to the power analysis, 18 people will participate in the study. Individuals with halluk valgus pain, deformity angle, balance, functional capacity, functionality, quality of life and kinesiophobia will be evaluated.After the individuals are evaluated, they will be randomly divided into 2 groups as the exercise group and the home exercise group.
All patients will be instructed on wearing appropriate footwear (made of soft material, with a wide round toe, with a normal heel height between 1 inch and 1.5 inches (2.5-3.8 cm). In addition, in order to increase the awareness of the participants, they will be asked to focus on how muscle activation feels during exercise and they will be asked to perform this activation during daily living activities.
The exercise program to be given to both groups will be the same, and will be applied with bare feet 4 days a week for 8 weeks. The exercise program will be advanced as recommended in the literature and 30 seconds of rest will be given between sets.
After the evaluation, all exercises will be shown to the home exercise group and it will be ensured that they are applied correctly. An illustrated and narrative exercise program brochure containing information about exercise position, number of repetitions, contraction time, rest time between sets, frequency and exercise diary will be given to the patient for exercise follow-up.
At the end of 8 weeks, the evaluations will be repeated by the same physiotherapist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Hallux Valgus
Keywords
hallux valgus, exercise, home program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise with a physiotherapist
Arm Type
Active Comparator
Arm Description
Participants will exercise with a physiotherapist. 4 times a week for 8 weeks
Arm Title
home program
Arm Type
Experimental
Arm Description
The same exercises will be given to the participants as brochures. 4 times a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Stretching the intrinsic muscles
Intervention Description
Participants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions.
Intervention Type
Other
Intervention Name(s)
Thumb Abduction with MTF Joint Traction
Intervention Description
participants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions.
Intervention Type
Other
Intervention Name(s)
Thumb active extension exercise
Intervention Description
An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. It will be desired to move the feet away from each other without moving the heels from the ground and the extension movement of the thumbs.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
Intervention Type
Other
Intervention Name(s)
Toe spread out
Intervention Description
In the first stage, active finger extension and abduction will be requested while the heel and metatarsal heads are in contact with the ground. In the second stage, while the other fingers are in extension, the smallest finger will be brought laterally and flexed to contact the ground. In the third stage, while in the second stage position, the thumb will be brought into abduction and flexion slowly and contact with the ground will be requested. These 3 phases will be repeated sequentially.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
Intervention Type
Other
Intervention Name(s)
Short foot
Intervention Description
While standing , the medial arch will be raised by trying to bring the metatarsal heads closer to the heel . The patient will be asked to move the big toe closer to the heel without bending the toes and without lifting the heel off the ground.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
Intervention Type
Other
Intervention Name(s)
Heel rise
Intervention Description
After taking a 5 cm high tape measure against the wall, the person will be asked to stand up on her heel by at least 5 cm.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
Intervention Type
Other
Intervention Name(s)
Towel toe curl
Intervention Description
Patients will be asked to place their feet on the edge of the towel on the floor. An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. Next, they will be asked to grasp the towel with their fingers, flexing their toes, and forcefully dragging them under their feet.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
Intervention Type
Other
Intervention Name(s)
Gastrocnemius active static stretching exercise
Intervention Description
The patient will be placed on the wall at eye level, 50 centimeters away from the wall. The leg that is desired to be stretched will be brought back, while the knee is straight, it will be requested to flex the front leg. During the test, it will be requested that the back heel does not rise from the ground and wait 30 seconds. 5 repetitions to be done
Intervention Type
Other
Intervention Name(s)
Plantar fascia and gastrocnemius stretching exercise on step
Intervention Description
The patient will be asked to place both feet on the step and slowly stretch the heel downwards until a stretch is felt in the arch of the foot and wait 30 seconds. 5 repetitions will be done
Primary Outcome Measure Information:
Title
hallux valgus angle
Description
The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.
Time Frame
Change from Baseline and at the end of 8 weeks
Secondary Outcome Measure Information:
Title
hallux valgus pain
Description
Hallux valgus pain will be measured with the VAS scale at the beginning and end of treatment.
Time Frame
Change from Baseline and at the end of 8 weeks
Title
Functional Status
Description
Static Balance Evaluation: It will be evaluated with the one-leg standing test.Dynamic Balance Evaluation: It will be evaluated by Y balance test.Functional capacity: To be evaluated with a 6-minute walk test.Foot Function Index (FFI): This index measures pain, function and activity limitation
Time Frame
Change from Baseline and at the end of 8 weeks
Title
life quality
Description
The SF-36 quality of life questionnaire will be used to assess general health-related quality of life.
Time Frame
Change from Baseline and at the end of 8 weeks
Title
kinesiophobia
Description
The Tampa Kinesiophobia Scale will be used to measure the fear of movement or re-injury.
Time Frame
Change from Baseline and at the end of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteer individuals between the ages of 18-64
Mild to moderate (15-40 degrees) hallux valgus
Bilateral hallux valgus
Have not received physical therapy for hallux valgus in the last 6 months,
Individuals who did not use orthotic devices or dynamic splints for the treatment of hallux valgus will be included in the study.
Exclusion Criteria:
HVA ≥ 45°
Rjjit hallux valgus deformity (in cases where the hallux cannot be brought to its normal position manually)
Obesity (BMI>30 kg/m2)
Systemic disease and inflammatory arthritis (rheumatoid arthritis, systemic lupus, diabetes mellitus)
Neurological disease (eg: neuropathy)
Vestibular disorder that may affect balance
History of standing trauma, fracture of the metatarophalangeal joint,
He has undergone foot-ankle surgery,
Using NSAIDs or analgesics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Betül Öztarsu
Phone
+903926303067
Email
mervebetuloztarsu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevim Öksüz, assist. prof.
Phone
+903926302473
Email
sevim.oksuz@emu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevim Öksüz, assist.prof.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Merve Betül Öztarsu
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra GÜÇHAN TOPCU
Phone
+903926303067
Ext
2496
Email
zehra.guchan@emu.edu.tr
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus
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