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CTRI Number  CTRI/2025/12/098411 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two braces in congenital muscular torticollis patients after surgery 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ujayant Bhardwaj 
Designation  Junior Resident  
Affiliation  Postgraduate Institute of Medical Education & Research  
Address  Room no 317 O block PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7018334283  
Fax    
Email  ujayant.bhardwaj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthick S R 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education & Research  
Address  Department of Orthopaedic ,PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9443324536  
Fax    
Email  drsrk05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ujayant Bhardwaj 
Designation  Junior Resident  
Affiliation  Postgraduate Institute of Medical Education & Research  
Address  Room no 317 O block PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7018334283  
Fax    
Email  ujayant.bhardwaj@gmail.com  
 
Source of Monetary or Material Support  
PGIMER 
 
Primary Sponsor  
Name  None 
Address  Not applicable 
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ujayant Bhardwaj  Postgraduate institute of medical science & education research  Advanced Paediatric Centre,5th Floor,Room No 5407
Chandigarh
CHANDIGARH 
7018334283

ujayant.bhardwaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post graduate institute of medical education and research, Chandigarh, institutional ethics, committee, (intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q680||Congenital deformity of sternocleidomastoid muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Distraction Orthosis  Distraction orthosis applied from post-operative day 2, full-time for first, six weeks except two hours per day for physiotherapy, then worn during 8 to 10 hours per day during Awake period for next six weeks, with the same physiotherapy protocol as for Head halter traction group 
Intervention  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 weaning for six weeks with concurrent passive stretching and active range of motion exercises 
Comparator Agent  Nil  Not applicable 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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 distractionorthosis  Pre operative,post operative 6weeks,3 months & 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
to estimate the cosmetic outcome as measured by Head tilt,scar, & lateral band
 
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 radiograph  Preoperative, post-operative six weeks, three months, & six months 
Patient compliance with distraction orthosis & Head alter traction   measured by percentage of hours device actually used against number of hours device prescribed 
Parents satisfaction using a five point, Likert -scale Questionnaire   Preoperative, post-operative six weeks, three months, & six months 
Complications, if any, such as recurrence rates & Skin issues  Preoperative, post-operative six weeks, three months, & six months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.

 
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