Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis

NCT02824848 | Terminated

• 2 other identifiers: 421 PT160161
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. In this randomized clinical trial, researchers will compare two physical therapy (PT) treatment methods, passive stretching and Perception-Action (P-A) Approach, in their effects on head position and use of both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly assigned to a passive stretching group or a P-A Approach group. The infants in both groups will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head position, the ability to turn the head to both sides, muscle strength on both sides of the neck, motor development, and use of both sides of the body for movement and play will be assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4. Results obtained from the two groups will be compared. It is hypothesized that:

1. 1.There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:
2. 2.Still photography
3. 3.Arthrodial goniometry used to assess active head rotation to both sides
4. 4.The Muscle Function Scale (MFS) used to assess neck muscle strength
5. 5.The Alberta Infant Motor Scale (AIMS) used to assess motor development
6. 6.There will be no significant difference between the groups on the above listed measures after the intervention is completed.
7. 7.The P-A Approach group will achieve greater gains than the passive stretching group between the initial and final assessments on the Functional Symmetry Observation Scale (FSOS) used to assess the use of both sides of the body for movement and play
8. 8.The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than the passive stretching group assigned based on participants' behavior demonstrated during PT intervention sessions

Conditions

Congenital Muscular Torticollis

Keywords

congenital muscular torticollis; infants; passive stretching; perception-action approach

Outcome Measures

Primary Outcomes (5)

• Still Photography

  Change in the angle of habitual head deviation from midline assessed in a supine position

  At baseline and week 5

• Arthrodial Goniometry

  Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides

  At baseline and week 5

• Muscle Function Scale (MFS)

  Change in the MFS score that reflects the difference in strength of lateral neck flexor muscles during head righting between the involved and uninvolved sides

  At baseline and week 5

• Functional Symmetry Observation Scale (FSOS)

  Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play

  At baseline and week 5

• Alberta Infant Motor Scale (AIMS)

  Change in the AIMS score that reflects gross motor development while also considering symmetrical postural alignment and symmetrical use of both sides of the body during movement and play

  At baseline and week 5

Secondary Outcomes (1)

• Therapy Behavior Scale (TBS)

  Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4)

Study Arms (2)

Passive Stretching

ACTIVE COMPARATOR

Passive Stretching intervention components include static passive stretching, active assistive range of motion, assisted stretching of the involved cervical musculature, and associated strengthening activities aimed to elicit head righting in developmentally appropriate positions and during developmentally appropriate movement transitions. Intervention is progressed by increasing head tilt angles, duration of head righting, and frequency and number of repetitions.

Behavioral: Passive Stretching

Perception-Action Approach

ACTIVE COMPARATOR

P-A Approach intervention components include environmental set-up for activity and participation in play, and manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions. Both components are designed to promote spontaneous exploration of the environment by the infant by suggesting small, incremental changes in his/her perceptual-motor orientation and contact with the support surface. Intervention is progressed by gradually removing environmental supports provided to the infant's body parts, and by removing the therapist's hands from the infant's body to allow for spontaneous exploration of a newly found contact with the support surface or new body configuration.

Behavioral: Perception-Action Approach

Interventions

Passive Stretching BEHAVIORAL

Passive stretching and associated strengthening activities to change head/neck and body alignment

Also known as: Passive movement, physical therapy

Passive Stretching

Perception-Action Approach BEHAVIORAL

Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities

Also known as: Perceptual-motor intervention, physical therapy

Perception-Action Approach

Eligibility Criteria

• Age: Up to 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between birth and 9 months at the time of recruitment
• diagnosis of congenital muscular torticollis as documented in the medical record
• Parents agree not to have their child participate in any additional interventions for CMT during the course of the study

You may not qualify if:

• other types of torticollis, such as neuromuscular torticollis, Sandifer syndrome, benign paroxysmal torticollis, ocular torticollis and other non-muscular types of torticollis, such as related to bony anomalies, which would warrant a referral back to the referring physician or to an appropriate specialist for diagnosis
• being seen for torticollis by another health care provider
• parents were using passive stretching with their infant prior to the study being offered to them AND would like to continue with passive stretching, but the child is assigned to the other intervention group
• parents were using Perception-Action Approach with their infant prior to the study being offered to them AND would like to continue with the same approach but the child is assigned to the other intervention group

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

Location

Related Publications (8)

• Kaplan SL, Coulter C, Fetters L. Physical therapy management of congenital muscular torticollis: an evidence-based clinical practice guideline: from the Section on Pediatrics of the American Physical Therapy Association. Pediatr Phys Ther. 2013 Winter;25(4):348-94. doi: 10.1097/PEP.0b013e3182a778d2.

  PMID: 24076627 BACKGROUND

• Rahlin M. TAMO therapy as a major component of physical therapy intervention for an infant with congenital muscular torticollis: a case report. Pediatr Phys Ther. 2005 Fall;17(3):209-18. doi: 10.1097/01.pep.0000179176.20035.f0.

  PMID: 16357675 BACKGROUND

• Cheng JC, Chen TM, Tang SP, Shum SL, Wong MW, Metreweli C. Snapping during manual stretching in congenital muscular torticollis. Clin Orthop Relat Res. 2001 Mar;(384):237-44. doi: 10.1097/00003086-200103000-00028.

  PMID: 11249171 BACKGROUND

• Tscharnuter I. Clinical Application of Dynamic Theory Concepts According to Tscharnuter Akademie for Movement Organization (TAMO) Therapy. Pediatr Phys Ther. 2002 Spring;14(1):29-37.

  PMID: 17053679 BACKGROUND

• Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.

  PMID: 21145518 BACKGROUND

• Rahlin M, Sarmiento B. Reliability of still photography measuring habitual head deviation from midline in infants with congenital muscular torticollis. Pediatr Phys Ther. 2010 Winter;22(4):399-406. doi: 10.1097/PEP.0b013e3181f9d72d.

  PMID: 21068640 BACKGROUND

• Blanchard Y, Neilan E, Busanich J, Garavuso L, Klimas D. Interrater reliability of early intervention providers scoring the alberta infant motor scale. Pediatr Phys Ther. 2004 Spring;16(1):13-8. doi: 10.1097/01.PEP.0000113272.34023.56.

  PMID: 17057466 BACKGROUND

• Rahlin M, McCloy C, Henderson R, Long T, Rheault W. Development and content validity of the Therapy Behavior Scale. Infant Behav Dev. 2012 Jun;35(3):452-65. doi: 10.1016/j.infbeh.2012.03.001. Epub 2012 Jun 26.

  PMID: 22729134 BACKGROUND

MeSH Terms

Conditions

Congenital torticollis

Interventions

Muscle Stretching Exercises; Range of Motion, Articular; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mary Rahlin, PT, DHS, PCS

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

• Nancy Haney, PT, MS

  Rady Children' Hospital, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2016
• First Posted: July 7, 2016
• Study Start: August 4, 2016
• Primary Completion: March 2, 2020
• Study Completion: May 6, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)