- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794334
Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.
December 26, 2023 updated by: Riphah International University
Effects Of Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.
To Check the effects of the low dye taping technique versus the Robert Debre method on foot posture and range of motion in children with club feet.
Study Overview
Detailed Description
This study was a Randomized clinical trial.
It was carried out in the physiotherapy department of children hospital Lahore,those patients were taken who had congenital clubfoot.40
patients were taken with the predetermined inclusive and exclusive criteria through non probability convenience sampling technique.All participants informed about the study,Group A received Low Dye taping Technique 2 times in a week for 6 weeks,while the group B received the Robert Debre Methpod daily 30 minutes session for total 6 weeks.Foot posture, range of motion and gait will be assessed by Demiglio bensahel and pirani scoring system with the help of goniometer and compared the results.Data analyzed by SPSS 25.0 statistical software.
After checking the normality of data nonparametric tests applied to check the difference between and within the groups.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Children Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 6 months (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- (1month to 6months ).
- Children having idiopathic club foot
- Unilateral or bilateral
- Severity by Dimeglio Bensahel scale we include moderate ,severe and very severe feet
Exclusion Criteria:
- Benign or non idiopathic.
- An associated syndrome or neurological disease.
- Positional club foot.
- Those previously treated with another method in other hospitals.
- Children with systemic diseases.
- Juvenile Arthritis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Dye Taping
: There were 20 patients in group A which received the low dye taping technique.
Low-dye is a classic taping method to reduces strain from plantar fascia and provide medial ankle arch support.
If properly applied, reduces subtalar joint motion, pain, excessive pronation.
Hence, it can be used in the treatment of ankle and foot.
|
This second group also contains 20 participents.French functional method is similar to the Ponseti method.
In this technique, the patient undergoes 30-minute daily session for 2 weeks and then twice a week until achieving foot correction.
It consists of stretching of triceps surae to improve tibio-talar joint function.
daily manipulations of the newborn's foot, stimulation and strenghtening of the muscles around the foot (particularly the peroneal muscles) and temporary immobilization of the foot with elastic and nonelastic adhesive taping so that the reduction achieved by.The average time of this method ranges between 6 to 8 weeks, with all the deformities being corrected apart from equinus.
This method reports a 93% success rate
Other Names:
|
|
Experimental: Robert Debre Method
This second group also contains 20 participents.French functional method is similar to the Ponseti method.
In this technique, the patient undergoes 30-minute daily session for 2 weeks and then twice a week until achieving foot correction.
It consists of stretching of triceps surae to improve tibio-talar joint function.
daily manipulations of the newborn's foot, stimulation and strenghtening of the muscles around the foot (particularly the peroneal muscles) and temporary immobilization of the foot with elastic and nonelastic adhesive taping so that the reduction achieved by.
|
This second group also contains 20 participents.French functional method is similar to the Ponseti method.
In this technique, the patient undergoes 30-minute daily session for 2 weeks and then twice a week until achieving foot correction.
It consists of stretching of triceps surae to improve tibio-talar joint function.
daily manipulations of the newborn's foot, stimulation and strenghtening of the muscles around the foot (particularly the peroneal muscles) and temporary immobilization of the foot with elastic and nonelastic adhesive taping so that the reduction achieved by.The average time of this method ranges between 6 to 8 weeks, with all the deformities being corrected apart from equinus.
This method reports a 93% success rate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Pirani scale:
Time Frame: 6th week
|
The Pirani scale scoring system describes 6 signs of contracture with a three point scale: 0= no abnormality, 0.5= moderate abnormality, 1= severe abnormality.
Scores for three midfoot signs (MFS) and three hindfoot signs (HFS), both with a maximum score of three are combined for a total score (TFS) out of six.
Increasing scores indicates increasing severity, with zero indicating an unaffected foot and six the most severe clubfoot.
|
6th week
|
|
The Dimeglio Bensahel Classification:
Time Frame: 6th week
|
The Dimeglio classification scores eight items; reducibility of four range of motion criteria and presence of four structural criteria.
Reducibility of equinus, varus, midfoot rotation and midfoot adductus is scored zero to four points.
The scores assigned to different degrees of reducibility of the deformity were specified by the author when the classification system was initially developed.The presence of four structural criteria; cavus, MC, PC, and muscle abnormality is also scored.
Structural criteria are scored as 0= absent or 1= present.
8 Scores for the four reducibility criteria and the four structural criteria combine for an overall score, with 20 indicating the most severe clubfoot and zero an unaffected foot.
|
6th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: fareeha kausar, pp-Dpt, Riphah International University Pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2022
Primary Completion (Actual)
April 16, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
February 20, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0738
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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