ClinicalTrials.gg
CompletedNCT05794334Updated Dec 27, 2023

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

An interventional study of Low Dye Taping in Club Foot, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 1 Month to 6 Months. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled May 2022, registered Feb 2023).

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Month to 6 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Clubfoot with a site in Pakistan — 4 open to participants now, 5 under way, none of them phase 3. Clubfoot · Pakistan.

Started
2022
the only one that year
No phase
8 of 10
3 open now
Registered
2nd of 10
by date
Lead sponsor
4 of 10
Riphah International University

Among the 10 studies in Clubfoot with a site in Pakistan, this one is the only one that started in 2022, is one of 8 with no phase, and was the 2nd registered.

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

Browse Clubfoot studies →

Open to participants now

4 of the 10 studies in Clubfoot with a site in Pakistan are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.

This study: 1 Month to 6 Months · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Clubfoot with a site in Pakistan, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Club Foot

Browse trials for

Keywords

  • Low dye taping
  • Robert Debre tecnique
04

Who can participate

Ages eligible
1 Month to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherLow 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

    Also known as: Robert Debre Technique

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6th week

  2. 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.

    Time frame: 6th week

07

Study locations

1 site
  • Children hospital
    Lahore, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2022 to primary completion in Apr 2023, 11 months.

Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 11 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2023
First posted
Apr 3, 2023
StartActual
May 13, 2022
Primary completionActual
Apr 16, 2023
CompletionActual
Apr 30, 2023
Last update
Dec 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05794334
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
May 13, 2022
Primary completion
Apr 16, 2023
Completion
Apr 30, 2023
Last update
Dec 27, 2023

Study contacts

fareeha kausar, pp-Dpt
principal investigator · Riphah international university pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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