An interventional study of Saleem's protocol in Congenital Talipes Equinovarus, sponsored by Pakistan Society for Rehabilitation of Differently Abled Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 1 Month to 1 Year. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Pakistan Society for Rehabilitation of Differently Abled Hospital · Not applicable, Interventional, and Treatment
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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.
Among the 10 studies in Clubfoot with a site in Pakistan, this one is the only one that started in 2023, is one of 8 with no phase, and was the 3rd registered.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
Browse Clubfoot studies →4 of the 10 studies in Clubfoot with a site in Pakistan are open now. Recruiting first, the newest first:
Khyber Medical University Peshawar · Sites in Pakistan
Ages 1 days–5 mo
Riphah International University · Sites in Pakistan
Ages 1 days–12 mo
Muhammad Aamir Latif · Sites in Pakistan
Ages 2–5
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 →
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 1 Year · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 1 started in 2023.
This study's planned enrollment of 15 is below the median of 38 across 40 interventional studies indexed under Clubfoot.
Median enrollment 26 across the 8 interventional studies, 73 across the 2 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 6 most frequent:
Pakistan Society for Rehabilitation of Differently Abled Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Pakistan Society for Rehabilitation of Differently Abled Hospital has 1 study filed under Clubfoot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Clubfoot with a site in Pakistan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The main objective of this study is to evaluate the effectiveness of Saleem's protocol treatment plan for congenital ideopathic talipes equino varus deformity using early tenotomy and serial foot casting. The combined effect of early tenotomies and foot serial casting has not been proven in prior investigations. Ten kids were involved in this pilot study where Saleem's protocol approach was used. With the use of the PIRANI score, the baseline reading was evaluated. Readings were obtained before each cast performance. This study results show's early correction of foot deformity with average 4 to 5 cast and no recurrence.
Congenital idiopathic clubfoot, also known as congenital talipes equinovarus, is the most common serious musculoskeletal birth defect that occurs in the United States and the world. Idiopathic clubfoot occurs in otherwise normal infants and should be distinguished from syndromic clubfoot and neurogenic clubfoot, which occur in infants as part of a syndrome or neurologic condition.Clubfoot is one of the most common congenital abnormalities affecting the lower limb, it remains a challenge not only to understand its genetic origins but also to provide effective long-term treatment. Various environmental influences have been shown to increase the risk of clubfoot in that they may affect the developing foetus in different ways including via genetic alterations, deformation, or growth arrest. The incidence has been reported to rise with increased maternal alcohol consumption], smoking, and if the mothers had undergone amniocentesis especially where a leak of amniotic fluid had occurred. In a clubfoot the soft tissues are more resistant to pressure than the bones.Untreated clubfoot causes life-long impairment, affecting individuals' ability to walk and participate in society.It can be isolated or associated with other serious congenital abnormalities, especially if bilateral and severe. The ideal aim of treatment is to achieve a functional, pain-free, plantigrade foot in the long term. Pirani scoring system is one of the classification systems and is simple, easy to use in the management of clubfoot.The Pirani scoring system works by assessing six clinical signs of contracture, which may score 0 (no deformity), 0.5 (moderate deformity) or 1(severe deformity). The total score is recorded after every visit. Pirani scoring is known to be valid and reliable for providing a good forecast about the potential treatment for an individual foot, such that a higher score at presentation may indicate the requirement of a higher number of casts to correct the deformity.
Different types of conservative methods (Ponseti techniques, Kite's method, and French physical therapy method). Six to 12 numbers of casts (mean: 10) were required in ponseti method to obtain correction of clubfoot deformities. Mean period of immobilization in a cast was 13.9 weeks (10-15 weeks). However, relapses are common in severe clubfeet and are probably caused by the same pathology that initiated the deformity. The rate of recurrence after using the Ponseti method, occurring in up to 40% of patient.Compliance with the Ponseti protocol is a major problem and has a direct effect on the success of treatment. Numerous surgeons have performed complete, plantar, lateral, medial, and posterior releases with poor results.
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Exclusion Criteria:
Early tenotomies and serial casting were used in Saleem's technique to reduce foot deforming forces. It involved 2 principal tenotmies and 2 accessory tenotmies. Principal tenotmies include tendo achillies and planter fascia release. 2 Accessory tenotmies include tibialis posterior and abductor hallucis. All tenotmies are done under local anesthesia.The foot is placed in a serial cast close to its natural anatomical position following tenotomies at first visit. children are evaluated after 1 week.This technique necessitates 4 to 5 casts on average. DB shoes were advised when the foot casting was finished, and a 6-month follow-up with the patient was conducted.
Procedure: Saleem's protocol
It involved 2 principal tenotmies and 2 accessory tenotmies. Principal tenotmies include tendo achillies and planter fascia release. 2 Accessory tenotmies include tibialis posterior and abductor hallucis. All tenotmies are done under local anesthesia
PIRANI Score
The Pirani Score is a simple and reliable system to determine severity and monitor progress in the Assessment and Treatment of Clubfoot.
Time frame: 6 months
Started Jul 2023 (actual). Primary completion is estimated for Aug 2024, 12 months after the start.
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 planned 12 months is close to that.
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Pakistan Society for Rehabilitation of Differently Abled Hospital