ExerciseNCT05000398
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
A study testing Stretching the intrinsic muscles, Thumb Abduction with MTF Joint Traction and Thumb active extension exercise in people with Exercise and Hallux Valgus, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Exercise, Hallux Valgus
- What is being tested?
- Stretching the intrinsic muscles, Thumb Abduction with MTF Joint Traction and Thumb active extension exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCyprus
- Study dates
- 24 May 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- History of standing trauma, fracture of the metatarophalangeal joint,
- He has undergone foot-ankle surgery,
- Using NSAIDs or analgesics
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Merve Betül Öztarsu
Famagusta, 99628
Zehra GÜÇHAN TOPCU, +903926303067 ext. 2496, zehra.guchan@emu.edu.tr
About this study
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).
Read the 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.
- Conditions
- Exercise, Hallux Valgus
- Being tested
- Stretching the intrinsic muscles, Thumb Abduction with MTF Joint Traction, Thumb active extension exercise, Toe spread out, Short foot
- Keywords
- hallux valgus, exercise, home program
- Medical subject headings
- Motor Activity, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching the intrinsic musclesOther
Participants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions.
Thumb Abduction with MTF Joint TractionOther
participants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions.
Thumb active extension exerciseOther
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.
Toe spread outOther
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.
Short footOther
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.
Heel riseOther
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.
Towel toe curlOther
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.
Gastrocnemius active static stretching exerciseOther
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
Plantar fascia and gastrocnemius stretching exercise on stepOther
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
| Study group | Role | What they receive |
|---|---|---|
| exercise with a physiotherapist | Active comparator | Participants will exercise with a physiotherapist. 4 times a week for 8 weeks Receives: Other: Stretching the intrinsic muscles; Other: Thumb Abduction with MTF Joint Traction; Other: Thumb active extension exercise; Other: Toe spread out; Other: Short foot; Other: Heel rise; Other: Towel toe curl; Other: Gastrocnemius active static stretching exercise; Other: Plantar fascia and gastrocnemius stretching exercise on step |
| home program | Experimental | The same exercises will be given to the participants as brochures. 4 times a week for 8 weeks Receives: Other: Stretching the intrinsic muscles; Other: Thumb Abduction with MTF Joint Traction; Other: Thumb active extension exercise; Other: Toe spread out; Other: Short foot; Other: Heel rise; Other: Towel toe curl; Other: Gastrocnemius active static stretching exercise; Other: Plantar fascia and gastrocnemius stretching exercise on step |
What is being measured
The primary outcome is the main question the study is designed to answer.
hallux valgus angle
The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.
Measured: Change from Baseline and at the end of 8 weeks
Secondary outcomes (4)
hallux valgus pain
Hallux valgus pain will be measured with the VAS scale at the beginning and end of treatment.
Measured: Change from Baseline and at the end of 8 weeks
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
Measured: Change from Baseline and at the end of 8 weeks
life quality
The SF-36 quality of life questionnaire will be used to assess general health-related quality of life.
Measured: Change from Baseline and at the end of 8 weeks
kinesiophobia
The Tampa Kinesiophobia Scale will be used to measure the fear of movement or re-injury.
Measured: Change from Baseline and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start24 May 2021
- Primary completion16 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Betül Öztarsu, Eastern Mediterranean University
- Investigators
- Sevim Öksüz, assist.prof., Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000398
- Sponsor's protocol ID
- BMerve
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05000398
- Acronym / sponsor ID
- BMerve
- Conditions
- Exercise, Hallux Valgus
- Keywords
- hallux valgus, exercise, home program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 16 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise with a physiotherapist | Active comparator | Other: Stretching the intrinsic muscles, Other: Thumb Abduction with MTF Joint Traction, Other: Thumb active extension exercise, Other: Toe spread out, Other: Short foot, Other: Heel rise, Other: Towel toe curl, Other: Gastrocnemius active static stretching exercise, Other: Plantar fascia and gastrocnemius stretching exercise on stepParticipants will exercise with a physiotherapist. 4 times a week for 8 weeks |
| home program | Experimental | Other: Stretching the intrinsic muscles, Other: Thumb Abduction with MTF Joint Traction, Other: Thumb active extension exercise, Other: Toe spread out, Other: Short foot, Other: Heel rise, Other: Towel toe curl, Other: Gastrocnemius active static stretching exercise, Other: Plantar fascia and gastrocnemius stretching exercise on stepThe same exercises will be given to the participants as brochures. 4 times a week for 8 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching the intrinsic musclesParticipants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions. | Other | exercise with a physiotherapist, home program |
| Thumb Abduction with MTF Joint Tractionparticipants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions. | Other | exercise with a physiotherapist, home program |
| Thumb active extension exerciseAn 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. | Other | exercise with a physiotherapist, home program |
| Toe spread outIn 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. | Other | exercise with a physiotherapist, home program |
| Short footWhile 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. | Other | exercise with a physiotherapist, home program |
| Heel riseAfter 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. | Other | exercise with a physiotherapist, home program |
| Towel toe curlPatients 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. | Other | exercise with a physiotherapist, home program |
| Gastrocnemius active static stretching exerciseThe 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 | Other | exercise with a physiotherapist, home program |
| Plantar fascia and gastrocnemius stretching exercise on stepThe 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 | Other | exercise with a physiotherapist, home program |
Primary outcome
hallux valgus angle
Time frame: Change from Baseline and at the end of 8 weeks
The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.
4 secondary outcomes
hallux valgus pain
Time frame: Change from Baseline and at the end of 8 weeks
Functional Status
Time frame: Change from Baseline and at the end of 8 weeks
life quality
Time frame: Change from Baseline and at the end of 8 weeks
kinesiophobia
Time frame: Change from Baseline and at the end of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Öksüz, assist.prof. study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching the intrinsic muscles, Thumb Abduction with MTF Joint Traction and Thumb active extension exercise in people with Exercise and Hallux Valgus, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Betül Öztarsu (+903926303067, mervebetuloztarsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hallux valgus angle (time frame: Change from Baseline and at the end of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.