NCT05794334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

February 20, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Low dye tapingRobert Debre tecnique

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Low Dye Taping

EXPERIMENTAL

: 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

Robert Debre Method

EXPERIMENTAL

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

Interventions

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

Also known as: Robert Debre Technique
Low Dye TapingRobert Debre Method

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (1month to 6months ).
  • Children having idiopathic club foot
  • Unilateral or bilateral
  • Severity by Dimeglio Bensahel scale we include moderate ,severe and very severe feet

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • fareeha kausar, pp-Dpt

    Riphah international university pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

April 3, 2023

Study Start

May 13, 2022

Primary Completion

April 16, 2023

Study Completion

April 30, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations