| 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 |
|
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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 |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [None] |
|
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Details of Secondary Sponsor
|
|
|
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
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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
|
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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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