Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis
NCT06957522 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-05-04
Summary
Who is this study for? This study is designed for infants aged 0-6 months who have been diagnosed with Congenital Muscular Torticollis (CMT). CMT is a condition observed at birth or shortly after, characterized by the shortening of the sternocleidomastoid (SCM) muscle, leading to the baby's head tilting to one side and rotating to the opposite side. It affects both boys and girls and may result in limited neck movement, abnormal posture, facial asymmetry, and potential developmental delays if left untreated.
What is the purpose of this study? The goal of this study is to compare the effectiveness of two different physical therapy methods-face-to-face rehabilitation and telerehabilitation-in treating infants with CMT. In addition to evaluating the outcomes of these two therapy methods, this research also aims to provide families with reliable, accessible information through a web-based educational platform.
Why is this study important? Early diagnosis and intervention are crucial for optimal recovery in infants with CMT. Studies show that infants who begin therapy by one month of age have up to a 98% chance of full recovery. However, if diagnosis and treatment are delayed, the recovery process can take longer and may be less effective. This study will help determine if online (telerehabilitation) sessions can be just as effective as traditional face-to-face therapy, offering a flexible and accessible treatment option for families.
What are the benefits of participating?
* Access to a structured, evidence-based rehabilitation program for your child
* Guidance from trained pediatric physiotherapists
* Increased awareness and knowledge about CMT through a web-based family education platform
* Contribution to research that may benefit other children and families in the future
* Evaluation of your baby's progress through professional assessments
What will the therapy program involve?
Participants will be randomly assigned to either a face-to-face or telerehabilitation group. Both groups will follow the same therapy program, focusing on:
* Increasing passive and active neck movements
* Promoting symmetrical head and body movement
* Providing recommendations for environmental adjustments
* Educating parents or caregivers on home-based exercises and care
Program structure:
* Face-to-face group: Therapy sessions will be conducted in a clinic setting, twice a week for 30 minutes each session, over a period of 8 weeks.
* Telerehabilitation group: Therapy sessions will be conducted via Zoom, with the same frequency, duration, and content as the face-to-face sessions.
How will outcomes be measured?
Infants will be assessed before and after the 8-week therapy period for:
* Passive cervical range of motion (rotation and lateral flexion)
* Gross motor function
* Muscle function Parental adherence to the home program will also be evaluated through a questionnaire. A follow-up will be conducted one month after therapy ends.
How can I participate? If your infant is aged 0-6 months and has been diagnosed with CMT, you may be eligible to participate. You will need access to a device with internet for telerehabilitation sessions, if assigned to that group. Participation is voluntary and free of charge. Families will receive detailed instructions and ongoing support throughout the program.
Additional Resources:
As part of this study, a web-based educational platform will be made available to all participating families. This platform will include:
* Clear explanations about CMT
* Instructional videos and home exercise guides
* Tips for daily care and positioning
* Frequently asked questions (FAQ) for parents Why is this research unique? This is one of the first studies to scientifically compare face-to-face and online rehabilitation for CMT infants, while also providing a reliable online resource for families. It aims to help develop alternative, flexible care models that meet the diverse needs of families and infants.
Contact Information:
If you are interested in participating or would like more information, please contact our research team at:
\[[email protected] / +905534646606\] We are committed to supporting your child's health and development. Thank you for considering being a part of this important study.
Conditions
- Infant
- Torticollis Congenital
- Neurodevelopment Treatment
- Telerehabilitation
- Physiotherapy and Rehabilitation
Interventions
- OTHER
-
face to face rehabilitation
The face-to-face rehabilitation program will be delivered in a clinical setting to infants aged 0-6 months with congenital muscular torticollis (CMT). It is based on neurodevelopmental treatment (NDT) principles and consists of: Passive range of motion (ROM) exercises for the neck Active ROM exercises for the neck and trunk Activities to promote the development of symmetrical movement Environmental modification suggestions for the home setting Parent/caregiver education and training Sessions will be conducted twice per week, 30 minutes per session, over a total of 8 weeks. In addition, an individualized home exercise program will be prescribed for each infant based on their specific needs. Frequency and duration of the home exercises may vary accordingly.
- OTHER
-
telerehabilitation
The telerehabilitation program provides the same therapeutic content as the face-to-face rehabilitation group but will be delivered remotely via the Zoom video conferencing platform. The program will be applied to infants aged 0-6 months with congenital muscular torticollis (CMT) and is based on neurodevelopmental treatment (NDT) principles, including: Passive range of motion (ROM) exercises for the neck Active ROM exercises for the neck and trunk Activities for symmetrical movement development Environmental modification suggestions Parent/caregiver education and guidance Sessions will be conducted via live video calls, twice per week, 30 minutes per session, for 8 weeks. Each family will also receive an individualized home exercise program, with its frequency and duration adapted to the infant's needs.
Sponsors & Collaborators
-
Istanbul University - Cerrahpasa
lead OTHER
Principal Investigators
-
Nilay Arman · Istanbul University-Cerrahpasa,Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation
-
GÖKÇEN EROL · Istanbul University-Cerrahpasa, Graduate School of Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Months
- Max Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-25
- Primary Completion
- 2026-09-25
- Completion
- 2026-12-25
Countries
- Turkey (Türkiye)
Study Locations
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