Hallux ValgusNCT06076655
Hallux Valgus Treatment Developed for Children With Cerebral Palsy
A study testing EXERCISE AND MOBILIZATION PROGRAM in people with Hallux Valgus, run by Istanbul Arel University.
Trial summary
This study is a clinical trial.Hallux valgus, one of the common deformities in the foot in children with diplegic Cerebral Palsy, has caused serious problems in daily life activities in children and has usually resulted in surgical operation. Read more about this study
- Who is it for?
- Ages 117 to 201 months
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- EXERCISE AND MOBILIZATION PROGRAM
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2023to 1 Jan 2024
- 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 117 to 201 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with cerebral palsy,
- Being a spastic diplegic type of cerebral palsy,
- Age range 9-16,
- Communication Function Classification System Level 1 and 2,
- Children with ambulatory level GMFCS 1-2,
- Using AFO and GRAFO,
- Children who do not use any assistive devices,
- Children with Manchester scale Stage 1 and 2 hallux valgus will be included in the study.
Who cannot join
- Those who cannot walk independently,
- GMSCS 3 and above,
- Does not use AFO and GRAFO,
- Children using assistive devices,
- Communication Function Classification System Level 3 and above,
- Manchester scale stage 3 hallux valgus,
- Children with spasticity values above 1+ according to the Modified Ashworth Scale will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Exercise and Mobilization in Correcting Deformity in Children With Diplegic Cerebral Palsy With Hallux Valgus
This study is a clinical trial.Hallux valgus, one of the common deformities in the foot in children with diplegic Cerebral Palsy, has caused serious problems in daily life activities in children and has usually resulted in surgical operation. Due to the lack of sufficient studies on this topic, our aim in our study is to show the importance of exercise and mobilization applied by physiotherapists in the early stages of hallux valgus deformity, which is common in children with Cerebral palsy, in correcting the deformity, and an example exercise program for physiotherapists.
The study will include 15 individuals with cerebral palsy diagnosed with hallux valgus by a physician at the Physiotherapy and Rehabilitation clinic at Istanbul FSM Madenler Medical Center according to the following criteria. Children diagnosed with diplegic SP, aged 9-16, with Communication Function Classification System Levels 1 and 2, ambulation level GMFCS 1-2, using AF Dec and GRAPHO and without any auxiliary device use, Manchester scale stages 1 and 2 will be included. Those who cannot walk independently, GMSCS 3 and above, children using assistive devices, Communication Function Classification System Level 3 and above, children with Manchester scale Stage 3 hallux valgus will be excluded from the study.Manchester November Scale for Hallux valgus classification, Hallux valgus angle and Foot and Ankle joint range of motion goniometer, Spasticity Modified Ashworth Scale (MAS), Foot and Ankle muscle strength Kendall Manual Muscle Strength Assessment, Pain Visual Analogue Scale (VAS), Communication skill Communication Function Classification System with Gross Motor Function Classification System GMFCS level, American orthopedic foot-ankle association-hallux MTF-IF scale evaluation is planned.
Read the detailed description
EXERCISE PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be performed twice a week in the rehabilitation unit accompanied by a physiotherapist, each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be performed for 12 weeks Dec. In addition, home exercises will be given 2 times a day and each exercise will be followed by 10 repetitions for 2 sets and 15 seconds Dec between sets.
The exercise and mobilization program planned to be implemented in this study for children with diplegic Cerebral Palsy is an exercise and mobilization program that has shown positive results in adults in various studies. We have created an exemplary protocol with the exercise and mobilization practices that were found effective in these studies. Below is our sample program.
Exercise and mobilization program to be implemented in the clinic accompanied by a physiotherapist:
- 1. Metatarsophalangeal Joint (MTFE) mobilization
- 1. MTF Traction mobilization
- 1. MTF medial and lateral shift mobilization
- 1. MTF dorso-plantar mobilization
- 1. MTF sesamoid mobilization
- Passive thumb abduction with thumb traction from the first metatarsophalangeal joint
- Toe Sequential Exercises
- 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
- 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
- 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
- Active thumb abduction
- Thumb abduction exercise with toe toe exercise rubber
- The movement of collecting sheets for active flexion of the ind November muscles of the foot
- Ball rolling exercise on the sole of the foot
- Active stretching exercise of the gastro-soleus November
- Hamstring November muscle active stretching exercise (Rose et al., 2020; Okur et al., 2019; Kim M-H et al.,2015)
Home exercise program to be given to the patient:
- Toe Sequential Exercises
- 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
- 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
- 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
- Active thumb abduction
- Thumb abduction exercise with Toe Toe Exercise Rubber
- The movement of collecting sheets for active flexion of the ind November muscles of the foot
- Ball rolling exercise on the sole of the foot
- Active stretching exercise of the gastro-soleus November
- Hamstring November muscle active stretching exercise
Evaluations will be performed 3 times before treatment, in the middle of treatment and at the end of treatment.
Exercise and mobilization performed alone as a result of treatment will prevent hallux valgus of seals in children with diplegic cerebral palsy, prevent surgical operation and provide an exemplary exercise protocol to physiotherapists.
- Conditions
- Hallux Valgus
- Being tested
- EXERCISE AND MOBILIZATION PROGRAM
- Keywords
- HALLUX VALGUS, CEREBRAL PALSY, EXERCISE, MOBILIZATION
- Medical subject headings
- Hallux Valgus, Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE AND MOBILIZATION PROGRAMOther
EXERCISE AND MOBILIZATION PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be applied twice a week in the rehabilitation unit under the supervision of a physiotherapist. Each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be carried out throughout the interval for 12 weeks. In addition, home exercises will be given twice a day, and each exercise will be followed in 2 sets of 10 repetitions with a 15-second interval between sets.
The exercise and mobilization program planned to be implemented in this study for children with diplegic cerebral palsy is an exercise and mobilization program that has yielded positive results in various studies in adults. We created a sample protocol with exercise and mobilization practices that were found effective in these studies.
What is being measured
The primary outcome is the main question the study is designed to answer.
COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS)
The aim of the communication function classification system is to classify daily communication performance between I and V levels in individuals with Cerebral Palsy.Dec.This classification is carried out with a form.Our aim is to include individuals who can express themselves in our study. Level 1 represents the effective receiver and transmitter with familiar and foreign partners, level 5 rarely represents the effective transmitter and receiver, even with familiar partners.
Measured: ONLY BEFORE TREATMENT
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM
Gross motor function in children with cerebral palsy is a standardized method that classifies motor function differences, especially in sitting and walking, into 5 levels. Level I walks without restriction; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility limited and may use motorized mobility device; Level V is transported in a hand-propelled wheelchair.
Measured: ONLY BEFORE TREATMENT
USE OF ORTHOSES AND ASSISTIVE DEVICES
A crıterıa has been prepared to questıon ıf there ıs an orthosıs ın the lower extremıtıty that chıldren wıth cerebral palsy use ın daıly lıfe, ıf any, what type of orthoses ıt ıs, and ıf they use assıstıve devıces.
Measured: ONLY BEFORE TREATMENT
PARTICIPANT EVALUATION FORM
The sociodemographic characteristics of the children were recorded and information such as name, surname, age, height, weight, gender, and body mass index were questioned. Factors causing the disease, accompanying diseases and extremity involvement are determined and recorded in the evaluation form.
Measured: ONLY BEFORE TREATMENT
Secondary outcomes (6)
MANCHESTER SCALE
This scale, which was developed to determine the degree of hallux valgus deformity in individuals; It is considered at 4 levels: none (1), mild (2), moderate (3), and severe (4) and is used as a clinical tool that includes photographs of the foot.Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
HALLUX VALGUS ANGLE
Measurements will be made using a universal goniometer. The first metatarsophalangeal joint was determined as the pivot point, and one arm of the goniometer was placed parallel to the articular joint. The first metatarsal bone is parallel to the proximal phalanx of the other arm and the hallux angle is recorded in degrees. Individuals with a toe hallux angle over 15 degrees are considered to have Hallux valgus. Measurements were taken 3 times before starting treatment, in the middle of treatment and at the end of treatment.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
KENDALL MANUAL MUSCLE STRENGTH ASSESSMENT
It will be used to evaluate November's muscle strength in children. This Test is scored Decently between 0 and 5.0 is the worst, 5 gives the best value. November November, the muscle groups to be evaluated were; MTF Flexion and Extension, IF Flexion and IF Extension Abduction of the big toe, plantar flexion of the ankle, dorsiflexion, eversion and inversion muscle groups were applied. Each assessment was repeated three times and the average was taken.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
VİSUAL ANALOGUE SCALE
It is used to evaluate possible change in pain intensity. It will be reported as no pain (0) and the worst pain imaginable (10). And the subjects will be asked to mark their pain at rest. Then, the marks on this line will be measured in centimeters and the results will be recorded. Measurements were taken 3 times before starting treatment, in the middle of treatment and at the end of treatment.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
AMERICAN ORTHOPEDIC FOOT-ANKLE ASSOCIATION HALLUX INTERPHALANGEAL JOINT SCALE
This 100-point scale is used to evaluate subjective and objective factors. Pain is evaluated as 40 points; function is evaluated as 45 points and alignment is evaluated as 15 points for a total of 100 points. If the patient has bilateral deformity, the result characteristics indicating the foot problem are recorded separately for both feet.Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
MODIFIED ASHWORTH SCALE
Modified Ashworth Scale (MAS) is used for spasticity. Hip Flexors, Hip Adductors, Rectus Femoris and hamstring muscle groups, Foot-ankle plantar flexion and dorsiflexion will be evaluated while the children lie on their backs in a comfortable position in bed. MAS is a 6-point scale that evaluates muscle tone.
0: No increase in tone and 4: Indicates that the involved part is rigid in flexion or extension. Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.
Measured: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start2 Oct 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedia ÖZDEMİR, Istanbul Arel University
- Investigators
- BEDİA ÖZDEMİR, Principal investigator, Istanbul Arel UniversitySEÇİL ÖZKURT, Study chair, Istanbul Arel UniversityOLCAY GÜLER, Study chair, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076655
- Sponsor's protocol ID
- IstanbulArelUBediaozdemir
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned that our individual participant data will be shared by mail with people who meet the appropriate Access Criteria.
Publications
Kim MH, Yi CH, Weon JH, Cynn HS, Jung DY, Kwon OY. Effect of toe-spread-out exercise on hallux valgus angle and cross-sectional area of abductor hallucis muscle in subjects with hallux valgus. J Phys Ther Sci. 2015 Apr;27(4):1019-22. doi: 10.1589/jpts.27.1019. Epub 2015 Apr 30.
PubMed 25995546
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise and Mobilization in Correcting Deformity in Children With Diplegic Cerebral Palsy With Hallux Valgus
- ClinicalTrials.gov ID
- NCT06076655
- Acronym / sponsor ID
- IstanbulArelUBediaozdemir
- Conditions
- Hallux Valgus
- Keywords
- HALLUX VALGUS, CEREBRAL PALSY, EXERCISE, MOBILIZATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Oct 2023 (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.
This study is a clinical trial.Hallux valgus, one of the common deformities in the foot in children with diplegic Cerebral Palsy, has caused serious problems in daily life activities in children and has usually resulted in surgical operation. Due to the lack of sufficient studies on this topic, our aim in our study is to show the importance of exercise and mobilization applied by physiotherapists in the early stages of hallux valgus deformity, which is common in children with Cerebral palsy, in correcting the deformity, and an example exercise program for physiotherapists.
The study will include 15 individuals with cerebral palsy diagnosed with hallux valgus by a physician at the Physiotherapy and Rehabilitation clinic at Istanbul FSM Madenler Medical Center according to the following criteria. Children diagnosed with diplegic SP, aged 9-16, with Communication Function Classification System Levels 1 and 2, ambulation level GMFCS 1-2, using AF Dec and GRAPHO and without any auxiliary device use, Manchester scale stages 1 and 2 will be included. Those who cannot walk independently, GMSCS 3 and above, children using assistive devices, Communication Function Classification System Level 3 and above, children with Manchester scale Stage 3 hallux valgus will be excluded from the study.Manchester November Scale for Hallux valgus classification, Hallux valgus angle and Foot and Ankle joint range of motion goniometer, Spasticity Modified Ashworth Scale (MAS), Foot and Ankle muscle strength Kendall Manual Muscle Strength Assessment, Pain Visual Analogue Scale (VAS), Communication skill Communication Function Classification System with Gross Motor Function Classification System GMFCS level, American orthopedic foot-ankle association-hallux MTF-IF scale evaluation is planned.
Detailed description
EXERCISE PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be performed twice a week in the rehabilitation unit accompanied by a physiotherapist, each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be performed for 12 weeks Dec. In addition, home exercises will be given 2 times a day and each exercise will be followed by 10 repetitions for 2 sets and 15 seconds Dec between sets.
The exercise and mobilization program planned to be implemented in this study for children with diplegic Cerebral Palsy is an exercise and mobilization program that has shown positive results in adults in various studies. We have created an exemplary protocol with the exercise and mobilization practices that were found effective in these studies. Below is our sample program.
Exercise and mobilization program to be implemented in the clinic accompanied by a physiotherapist:
- 1. Metatarsophalangeal Joint (MTFE) mobilization
- 1. MTF Traction mobilization
- 1. MTF medial and lateral shift mobilization
- 1. MTF dorso-plantar mobilization
- 1. MTF sesamoid mobilization
- Passive thumb abduction with thumb traction from the first metatarsophalangeal joint
- Toe Sequential Exercises
- 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
- 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
- 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
- Active thumb abduction
- Thumb abduction exercise with toe toe exercise rubber
- The movement of collecting sheets for active flexion of the ind November muscles of the foot
- Ball rolling exercise on the sole of the foot
- Active stretching exercise of the gastro-soleus November
- Hamstring November muscle active stretching exercise (Rose et al., 2020; Okur et al., 2019; Kim M-H et al.,2015)
Home exercise program to be given to the patient:
- Toe Sequential Exercises
- 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
- 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
- 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
- Active thumb abduction
- Thumb abduction exercise with Toe Toe Exercise Rubber
- The movement of collecting sheets for active flexion of the ind November muscles of the foot
- Ball rolling exercise on the sole of the foot
- Active stretching exercise of the gastro-soleus November
- Hamstring November muscle active stretching exercise
Evaluations will be performed 3 times before treatment, in the middle of treatment and at the end of treatment.
Exercise and mobilization performed alone as a result of treatment will prevent hallux valgus of seals in children with diplegic cerebral palsy, prevent surgical operation and provide an exemplary exercise protocol to physiotherapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 117 to 201 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Being diagnosed with cerebral palsy,
- Being a spastic diplegic type of cerebral palsy,
- Age range 9-16,
- Communication Function Classification System Level 1 and 2,
- Children with ambulatory level GMFCS 1-2,
Key exclusion criteria (7 listed)
- Those who cannot walk independently,
- GMSCS 3 and above,
- Does not use AFO and GRAFO,
- Children using assistive devices,
- Communication Function Classification System Level 3 and above,
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 |
|---|---|---|
| EXERCISE AND MOBILIZATION PROGRAMEXERCISE AND MOBILIZATION PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be applied twice a week in the rehabilitation unit under the supervision of a physiotherapist. Each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be carried out throughout the interval for 12 weeks. In addition, home exercises will be given twice a day, and each exercise will be followed in 2 sets of 10 repetitions with a 15-second interval between sets. The exercise and mobilization program planned to be implemented in this study for children with diplegic cerebral palsy is an exercise and mobilization program that has yielded positive results in various studies in adults. We created a sample protocol with exercise and mobilization practices that were found effective in these studies. | Other | – |
Primary outcome
COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS)
Time frame: ONLY BEFORE TREATMENT
The aim of the communication function classification system is to classify daily communication performance between I and V levels in individuals with Cerebral Palsy.Dec.This classification is carried out with a form.Our aim is to include individuals who can express themselves in our study. Level 1 represents the effective receiver and transmitter with familiar and foreign partners, level 5 rarely represents the effective transmitter and receiver, even with familiar partners.
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM
Time frame: ONLY BEFORE TREATMENT
Gross motor function in children with cerebral palsy is a standardized method that classifies motor function differences, especially in sitting and walking, into 5 levels. Level I walks without restriction; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility limited and may use motorized mobility device; Level V is transported in a hand-propelled wheelchair.
USE OF ORTHOSES AND ASSISTIVE DEVICES
Time frame: ONLY BEFORE TREATMENT
A crıterıa has been prepared to questıon ıf there ıs an orthosıs ın the lower extremıtıty that chıldren wıth cerebral palsy use ın daıly lıfe, ıf any, what type of orthoses ıt ıs, and ıf they use assıstıve devıces.
PARTICIPANT EVALUATION FORM
Time frame: ONLY BEFORE TREATMENT
The sociodemographic characteristics of the children were recorded and information such as name, surname, age, height, weight, gender, and body mass index were questioned. Factors causing the disease, accompanying diseases and extremity involvement are determined and recorded in the evaluation form.
6 secondary outcomes
MANCHESTER SCALE
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
HALLUX VALGUS ANGLE
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
KENDALL MANUAL MUSCLE STRENGTH ASSESSMENT
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
VİSUAL ANALOGUE SCALE
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
AMERICAN ORTHOPEDIC FOOT-ANKLE ASSOCIATION HALLUX INTERPHALANGEAL JOINT SCALE
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
MODIFIED ASHWORTH SCALE
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 25995546Kim MH, Yi CH, Weon JH, Cynn HS, Jung DY, Kwon OY. Effect of toe-spread-out exercise on hallux valgus angle and cross-sectional area of abductor hallucis muscle in subjects with hallux valgus. J Phys Ther Sci. 2015 Apr;27(4):1019-22. doi: 10.1589/jpts.27.1019. Epub 2015 Apr 30.
- The effects of taping and foot exercises on patients with hallux valgus: a preliminary studyLink provided by the sponsor.
- EVALUATION OF THE EFFICACY OF MANUAL MOBILIZATION TECHNIQUES IN THE TREATMENT OF HALLUX RIGIDUS: CASE SERIESLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. It is planned that our individual participant data will be shared by mail with people who meet the appropriate Access Criteria.
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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.
BEDİA ÖZDEMİR principal investigator
Istanbul Arel University
SEÇİL ÖZKURT study chair
Istanbul Arel University
OLCAY GÜLER study chair
Istanbul Arel University
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE AND MOBILIZATION PROGRAM in people with Hallux Valgus, run by Istanbul Arel University.
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 8 inclusion and 7 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 BEDİA ÖZDEMİR (+905439422765, fzt.bediaozdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS) (time frame: ONLY BEFORE TREATMENT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076655, which also lists 1 linked publication.
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 12 Oct 2023.