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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 6 months (Child)

Accepts Healthy Volunteers

No

Description

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other Names:
  • Robert Debre Technique
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.
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
Other Names:
  • Robert Debre Technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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