- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663721
The Effects of Weight Shift Training on the Symmetry of Upper Extremity Weight Bearing in the Prone Position in Infants With Congenital Muscular Torticollis
Congenital muscular torticollis(CMT) is a common musculoskeletal condition in infancy that may result in asymmetrical posture and weight-bearing patterns, limited cervical range of motion, and delayed motor development. This randomized controlled trial aims to investigate the effects of weight shift training on upper extremity weight-bearing symmetry in infants with CMT.
A total of 30 infants aged 6 to 12 months diagnosed with CMT will be randomly assigned to either an experimental group(n = 15) or a control group(n = 15). The experimental group will receive weight shift training in prone and sitting positions in addition to stretching exercises, while the control group will receive stretching exercises only. Both groups will participate in 30-minute intervention sessions three times per week for eight weeks.
The primary outcome is upper extremity weight-bearing symmetry, which will be assessed using the Balancia software system. Secondary outcomes include motor development assessed by the Alberta Infant Motor Scale(AIMS), head tilt angle, and passive cervical rotation range of motion. The findings of this study may provide evidence regarding the effectiveness of weight shift training in improving postural symmetry and motor function in infants with congenital muscular torticollis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Congenital muscular torticollis(CMT) is a musculoskeletal condition characterized by unilateral shortening or tightness of the sternocleidomastoid muscle, resulting in head tilt, limited cervical range of motion, and postural asymmetry. Infants with CMT frequently demonstrate asymmetrical weight bearing patterns.
Early physical therapy interventions, including stretching exercises, are widely used to improve cervical mobility and reduce postural asymmetry. However, interventions specifically targeting symmetrical weight bearing and postural control may provide additional benefits by promoting more symmetrical development in functional activities.
Weight shift training encourages active transfer of body weight while maintaining postural stability. Improved weight bearing symmetry may contribute to more efficient motor development and functional movement patterns in infants with CMT.
The purpose of this study is to determine whether the addition of weight shift training to conventional stretching exercises improves upper extremity weight-bearing symmetry, motor development, head posture, and cervical mobility in infants with congenital muscular torticollis. The findings of this study may provide evidence for the clinical effectiveness of incorporating weight shift training into rehabilitation programs for infants with CMT.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: junyeong Heo, PT
- Phone Number: +82-10-4206-3290
- Email: hamstering99@naver.com
Study Locations
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Gyeonggi-do
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Yongin-si, Gyeonggi-do, South Korea, 16943
- EZ Rehabilitation Medicine Clinic
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Contact:
- junyeong Heo, PT
- Phone Number: +82-10-4206-3290
- Email: hamstering99@naver.com
-
Principal Investigator:
- junyeong Heo, PT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with congenital muscular torticollis by a physician
- Head tilt angle of 15 degrees or greater and limitation of passive cervical rotation range of motion
- Able to independently maintain the prone position and demonstrate asymmetrical upper extremity weight bearing
Exclusion Criteria:
- Diagnosed with non-muscular torticollis, including postural torticollis or ocular torticollis
- Presence of congenital cervical spine abnormalities or neurological complications
- Any medical condition that may interfere with participation in the intervention or outcome assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weight Shift Training + Stretching
Experimental groups will receive weight shift training in prone and sitting positions in addition to stretching exercises.
The intervention will be provided for 30 minutes per session, three times per week, for eight weeks.
|
Weight shift training will be performed in prone and sitting positions to facilitate symmetrical weight bearing and postural control in infants with congenital muscular torticollis.
Stretching exercises will be performed to improve head tilt and cervical range of motion in infants with congenital muscular torticollis.
|
|
Active Comparator: Stretching Only
Control groups will receive stretching exercises only.
The intervention will be provided for 30 minutes per session, three times per week, for eight weeks.
|
Stretching exercises will be performed to improve head tilt and cervical range of motion in infants with congenital muscular torticollis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symmetry of Upper Extremity Weight Bearing in the Prone Position
Time Frame: Baseline and Week 8
|
Symmetry of Upper extremity weight bearing in the prone position will be assessed using the Balancia software system.
Weight bearing distribution between the left and right upper extremities will be measured.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head tilt
Time Frame: Baseline and Week 8
|
Head tilt will be measured to evaluate postural asymmetry associated with congenital muscular torticollis.
|
Baseline and Week 8
|
|
Cervical rotation passive range of motion
Time Frame: Baseline and Week 8
|
Cervical rotation passive range of motion will be measured using standard clinical assessment procedures.
|
Baseline and Week 8
|
|
Motor Development Assessed by the Alberta Infant Motor Scale
Time Frame: Baseline and Week 8
|
Motor development will be assessed using the Alberta Infant Motor Scale.
The Alberta Infant Motor Scale is an observational measure of infant motor development with scores ranging from 0 to 58, where higher scores indicate better motor development.
|
Baseline and Week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: junyeong Heo, PT, Sahmyook University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYU 2026-04-026-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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