An interventional study of EXERCISE AND MOBILIZATION PROGRAM in Hallux Valgus, sponsored by Istanbul Arel University. Not yet recruiting. Open to participants aged 117 Months to 201 Months. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Istanbul Arel University · Not applicable, Interventional, and Treatment
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.
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:
Metatarsophalangeal Joint (MTFE) mobilization
Toe Sequential Exercises
Home exercise program to be given to the patient:
Toe Sequential Exercises
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 15 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Istanbul Arel University is the lead sponsor of 44 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: ONLY BEFORE TREATMENT
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
No study locations are listed for this record.
Plan to share: Yes — It is planned that our individual participant data will be shared by mail with people who meet the appropriate Access Criteria.
Supporting information: Study protocol
Time frame: Dec January October 2023 to January 2024 is planned for our study.
Access criteria: Magazine editor Members of the ethics committee
Start is estimated for Oct 2023; primary completion for Jan 2024, 2 months later.
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.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Arel University