NCT07663721

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 17, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Congenital Muscular TorticollisWeight Shift TrainingUpper Extremity Weight Bearing SymmetryPostural ControlAlberta Infant Motor ScaleHead TiltCervical Range of Motion

Outcome Measures

Primary Outcomes (1)

  • Symmetry of Upper Extremity Weight Bearing in the Prone Position

    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 Outcomes (3)

  • Head tilt

    Baseline and Week 8

  • Cervical rotation passive range of motion

    Baseline and Week 8

  • Motor Development Assessed by the Alberta Infant Motor Scale

    Baseline and Week 8

Study Arms (2)

Weight Shift Training + Stretching

EXPERIMENTAL

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.

Other: Weight Shift TrainingOther: Stretching Exercise

Stretching Only

ACTIVE COMPARATOR

Control groups will receive stretching exercises only. The intervention will be provided for 30 minutes per session, three times per week, for eight weeks.

Other: Stretching Exercise

Interventions

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.

Weight Shift Training + Stretching

Stretching exercises will be performed to improve head tilt and cervical range of motion in infants with congenital muscular torticollis.

Stretching OnlyWeight Shift Training + Stretching

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EZ Rehabilitation Medicine Clinic

Yongin-si, Gyeonggi-do, 16943, South Korea

Location

MeSH Terms

Conditions

Congenital torticollis

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • junyeong Heo, PT

    Sahmyook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the experimental group or the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available to protect participant confidentiality.

Locations