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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05794334
Other study ID # REC/RCR & AHS/22/0738
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2022
Est. completion date April 30, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 30, 2023
Est. primary completion date April 16, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 6 Months
Eligibility Inclusion Criteria: 1. (1month to 6months ). 2. Children having idiopathic club foot 3. Unilateral or bilateral 4. Severity by Dimeglio Bensahel scale we include moderate ,severe and very severe feet Exclusion Criteria: 1. Benign or non idiopathic. 2. An associated syndrome or neurological disease. 3. Positional club foot. 4. Those previously treated with another method in other hospitals. 5. Children with systemic diseases. 6. Juvenile Arthritis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low Dye Taping
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

Locations

Country Name City State
Pakistan Children hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Pirani scale: 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
Primary The Dimeglio Bensahel Classification: 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
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