ClinicalTrials.gg
Status unknownNCT05000398Updated Aug 11, 2021

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

An interventional study of Stretching the intrinsic muscles and Thumb Abduction with MTF Joint Traction in Exercise and Hallux Valgus, sponsored by Eastern Mediterranean University. Status unknown at 1 site in Cyprus. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-08-11.

Primary conditionHallux ValgusRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hallux Valgus
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Hallux Valgus.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Exercise
  • Hallux Valgus

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Keywords

  • hallux valgus
  • exercise
  • home program
03

In context

Hallux Valgus Reclassified

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 18 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 17 are open to participants now.

Compared within Hallux Valgus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • HVA ≥ 45°
  • Rjjit hallux valgus deformity (in cases where the hallux cannot be brought to its normal position manually)
  • Obesity (>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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    exercise with a physiotherapist

    Participants will exercise with a physiotherapist. 4 times a week for 8 weeks

    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

  • Experimental
    home program

    The same exercises will be given to the participants as brochures. 4 times a week for 8 weeks

    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

Interventions

  • OtherStretching the intrinsic muscles

    Participants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions.

  • OtherThumb Abduction with MTF Joint Traction

    participants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions.

  • OtherThumb active extension exercise

    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.

  • OtherToe spread out

    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.

  • OtherShort foot

    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.

  • OtherHeel rise

    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.

  • OtherTowel toe curl

    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.

  • OtherGastrocnemius active static stretching exercise

    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

  • OtherPlantar fascia and gastrocnemius stretching exercise on step

    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

06

What researchers measure

Primary outcomes

  1. hallux valgus angle

    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 outcomes

  1. hallux valgus pain

    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

  2. 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

    Time frame: Change from Baseline and at the end of 8 weeks

  3. life quality

    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

  4. kinesiophobia

    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

07

Study locations

1 of 1 sites recruiting
  • Merve Betül Öztarsu
    Famagusta, 99628, Cyprus
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2021 (actual). Primary completion is estimated for Aug 2021, 2 months after the start.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 2 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2021
First posted
Aug 11, 2021
StartActual
May 24, 2021
Primary completionEst.
Aug 16, 2021
CompletionEst.
Sep 1, 2021
Last update
Aug 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05000398
Responsible party
Merve Betül Öztarsu (physiotherapist, Eastern Mediterranean University) — Principal investigator
First posted
Aug 11, 2021
Start date
May 24, 2021
Primary completion
Aug 16, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
Aug 11, 2021

Study contacts

Merve Betül Öztarsu
Contact
mervebetuloztarsu@gmail.com
+903926303067
Sevim Öksüz, assist. prof.
Contact
sevim.oksuz@emu.edu.tr
+903926302473
Sevim Öksüz, assist.prof.
study director · Eastern Mediterranean University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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