Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis

NCT06957522 | Not Yet Recruiting

• 1 other identifier: GErol1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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: \[fgokcenalaca@gmail.com / +905534646606\] 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

Keywords

telerehabilitation; congenital torticollis; infant; neurodevelopment treatment; physiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (2)

• Passive Cervical Range of Motion (Lateral Flexion and Rotation)

  Passive range of motion (ROM) of the neck, specifically lateral flexion and rotation, will be assessed using an arthrodial goniometer. Measurements will be taken at three time points: Baseline (Pre-intervention) Post-intervention (At the end of 8 weeks of rehabilitation) Follow-up (1 month after the end of the intervention) This outcome aims to evaluate changes in cervical mobility in response to the rehabilitation programs.

  Baseline, Week 8 (post-treatment), and 1-month follow-up

• Head Tilt Angle (Still Photography Method)

  Head tilt will be assessed using the Still Photography Method, a standardized photographic procedure: A photograph of the infant is taken in a supin position. A horizontal line is drawn connecting the pupils of both eyes (inter-pupillary line). A second line is drawn connecting the acromion processes of both shoulders. The acute angle between these two lines is measured to quantify the degree of head tilt. This method allows for an objective and reliable evaluation of head posture asymmetry in infants with congenital muscular torticollis (CMT).

  Baseline, Week 8 (post-treatment), and 1-month follow-up

Secondary Outcomes (2)

• Muscle Function Test (MFT)

  Baseline, Week 8 (post-treatment), and 1-month follow-up

• Alberta Infant Motor Scale (AIMS)

  Baseline, Week 8 (post-treatment), and 1-month follow-up

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

The telerehabilitation group receives the same structured, neurodevelopmentally-based rehabilitation program as the face-to-face group. However, the delivery method-via online video conferencing (Zoom)-represents a novel mode of application for this specific intervention in infants with congenital muscular torticollis (CMT). To date, this therapeutic program has not been delivered through telehealth for this population, and its feasibility, effectiveness, and comparability to the conventional face-to-face method have not yet been studied. Therefore, this arm is considered experimental as it involves a new and previously untested method of intervention delivery, even though the therapeutic content remains the same.

Other: telerehabilitation

Face to face rehabilitation

ACTIVE COMPARATOR

The face-to-face rehabilitation group receives a structured, neurodevelopmental treatment program that is already in routine clinical use for infants with congenital muscular torticollis (CMT). It represents the current standard method of delivering this intervention in clinical settings. Since the objective of the study is to compare the effectiveness of a novel telerehabilitation delivery model against this established, routinely used face-to-face method, the face-to-face arm serves as the active comparator. This arm provides a baseline for evaluating the outcomes of the experimental telerehabilitation approach.

Other: face to face rehabilitation

Interventions

face to face rehabilitation OTHER

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.

Face to face rehabilitation

telerehabilitation OTHER

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.

Telerehabilitation

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 0 to 6 months
• Diagnosed with congenital muscular torticollis (CMT)
• Classified as Grade 1 to 3 CMT severity based on clinical assessment

You may not qualify if:

• Plagiocephaly
• Ocular torticollis
• Neurological complications
• Musculoskeletal disorders of the cervical spine
• Visual impairments
• Hearing impairments

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa, Faculty of Health Sciences, Büyükçekmece Campus, Alkent 2000 Mah. Yiğittürk Street No:5/9/1, Büyükçekmece/Istanbul, Turkey

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (4)

• Rodriguez-Huguet M, Rodriguez-Almagro D, Rosety-Rodriguez MA, Vinolo-Gil MJ, Ayala-Martinez C, Gongora-Rodriguez J. Effectiveness of the Treatment of Physiotherapy in the Congenital Muscular Torticollis: A Systematic Review. Children (Basel). 2023 Dec 20;11(1):8. doi: 10.3390/children11010008.

  PMID: 38275429 RESULT

• Sargent B, Coulter C, Cannoy J, Kaplan SL. Physical Therapy Management of Congenital Muscular Torticollis: A 2024 Evidence-Based Clinical Practice Guideline From the American Physical Therapy Association Academy of Pediatric Physical Therapy. Pediatr Phys Ther. 2024 Oct 1;36(4):370-421. doi: 10.1097/PEP.0000000000001114. Epub 2024 Oct 1.

  PMID: 39356257 RESULT

• Castilla A, Gonzalez M, Kysh L, Sargent B. Informing the Physical Therapy Management of Congenital Muscular Torticollis Clinical Practice Guideline: A Systematic Review. Pediatr Phys Ther. 2023 Apr 1;35(2):190-200. doi: 10.1097/PEP.0000000000000993. Epub 2023 Jan 10.

  PMID: 36637442 RESULT

• Kaplan SL, Coulter C, Sargent B. Physical Therapy Management of Congenital Muscular Torticollis: A 2018 Evidence-Based Clinical Practice Guideline From the APTA Academy of Pediatric Physical Therapy. Pediatr Phys Ther. 2018 Oct;30(4):240-290. doi: 10.1097/PEP.0000000000000544.

  PMID: 30277962 RESULT

MeSH Terms

Conditions

Congenital torticollis

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nilay Arman

  Istanbul University-Cerrahpasa,Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• GÖKÇEN EROL

  Istanbul University-Cerrahpasa, Graduate School of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gökçen EROL

CONTACT

+90553-464-66-06; fgokcenalaca@gmail.com

Nilay ARMAN

CONTACT

+90553-455-87-07; nilayarman@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist

Model Details: The study will compare the effectiveness of face-to-face and telerehabilitation methods in infants diagnosed with congenital muscular torticollis aged 0-6 months. The sample size was determined as 42 by preliminary analysis. Infants diagnosed with congenital muscular torticollis aged 0-6 months, who meet the inclusion criteria and whose parents volunteer to participate in the exercise program will be included in the study. Infants whose parents sign the informed consent form will be included in the study. Participants will be divided equally into two groups (face-to-face rehabilitation group and telerehabilitation group) (n=21) by simple randomization method. Treatment will be applied to both groups for 8 weeks, 2 days a week and each session will be 30 minutes. The treatment content includes exercises to increase active neck range of motion, activities supporting symmetrical movements, family education, home program and practices supporting gross motor development.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)