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Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.

Primary Purpose

Club Foot

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low Dye Taping
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Club Foot focused on measuring Low dye taping, Robert Debre tecnique

Eligibility Criteria

1 Month - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dye Taping

Robert Debre Method

Arm Description

: 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05794334
Brief Title
Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.
Official Title
Effects Of Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
April 16, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Club Foot
Keywords
Low dye taping, Robert Debre tecnique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dye Taping
Arm Type
Experimental
Arm Description
: 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.
Arm Title
Robert Debre Method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low Dye Taping
Other Intervention Name(s)
Robert Debre Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
The Pirani scale:
Description
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.
Time Frame
6th week
Title
The Dimeglio Bensahel Classification:
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mishal Shansi, MS
Phone
03319773117
Email
mishalshamsi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fareeha kausar, pp-Dpt
Organizational Affiliation
Riphah international university pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.

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