Comparison of post - operative rehabilitation protocol of head halter traction vs distraction orthosis after bipolar release in congenital muscular torticollis . A Single Blinded,Non inferiority Randomized Controlled Trial

The trial is designed to compare two different postoperative rehabilitation methods—head halter traction and distraction orthosis—used after bipolar release surgery in children with congenital muscular torticollis (CMT), with the aim of determining which is at least as effective or better in maintaining correction and improving function and cosmesis.

Congenital muscular torticollis is caused by unilateral shortening or fibrosis of the sternocleidomastoid muscle, leading to head tilt, limited neck range of motion, and potential long-term deformities such as facial asymmetry and cranial and spinal imbalance if not treated adequately.[1] While bipolar release surgery is an established treatment in older children with refractory CMT, long-term outcomes depend heavily on the quality of postoperative rehabilitation, for which both head halter traction and distraction orthoses are currently used but have not been rigorously compared head-to-head.[1]

Purpose of the trial

The primary purpose of this single-blinded non-inferiority randomized controlled trial is to estimate and compare functional outcomes, using the modified Lee score, in children aged 3–10 years undergoing bipolar release for CMT who are rehabilitated either with head halter traction or with a distraction orthosis.[1] Secondary purposes include comparing cosmetic and radiological outcomes, device compliance, parent satisfaction, and complication profiles between the two protocols, in order to generate evidence-based guidance on the optimal postoperative rehabilitation strategy after bipolar release in CMT.