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Comparison of two braces in congenital muscular torticollis patients after surgery

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098411
Enrollment
18
Registered
2025-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q680- Congenital deformity of sternocleidomastoid muscle

Interventions

Intervention1: Head Halter Traction: Head halter traction starting 48 -72 hours after bipolar release surgery, full time for three weeks, except two hours/day for physiotherapy, followed by gradual we

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children diagnosed with congenital muscular torticollis, not responding to physiotherapy and undergoing bipolar surgical release 2)unilateral congenital muscular torticollis due to SCM tightness 3)individuals who are willing to participate in the study and provide consent

Exclusion criteria

Exclusion criteria: 1) other causes of tort like traumatic, infective, malignancy, cervical spine pathology 2) any history of previous surgery of torticollis 3) inability to comply with rehabilitation protocol 4) unipolar release 5) Patients unwilling to participate in the study

Design outcomes

Primary

MeasureTime frame
to estimate and compare the functional outcomes using modified Lee score of CMT children undergoing bipolar release, having post operative rehabilitation with Head halter versus distractionorthosisTimepoint: Pre operative,post operative 6weeks,3 months & 6 months

Secondary

MeasureTime frame
to estimate the cosmetic outcome as measured by Head tilt,scar, & lateral band Timepoint: Preoperative, post-operative 6weeks 3months & 6 months;to determine radiological outcome as measured by CMA, C2 -T1 distance, clavicle angle & C2 -C7 angle using AP & lateral cervical spine radiographTimepoint: Preoperative, post-operative six weeks, three months, & six months;Patient compliance with distraction orthosis & Head alter tractionTimepoint: measured by percentage of hours device actually used against number of hours device prescribed;Parents satisfaction using a five point, Likert -scale QuestionnaireTimepoint: Preoperative, post-operative six weeks, three months, & six months;Complications, if any, such as recurrence rates & Skin issuesTimepoint: Preoperative, post-operative six weeks, three months, & six months

Countries

India

Contacts

Public ContactDr Ujayant Bhardwaj

Postgraduate Institute of Medical Education & Research

drsrk05@gmail.com9443324536

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026