NCT02824848

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

Terminated NA Last updated 12 May 2020

What this trial tests

NA trial testing Passive Stretching in Congenital Muscular Torticollis in 32 participants. Terminated before completion.

Timeline

4 August 2016

Primary endpoint
2 March 2020

6 May 2020

Quick facts

Lead sponsor	Rosalind Franklin University of Medicine and Science
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	32
Start date	4 August 2016
Primary completion	2 March 2020
Estimated completion	6 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Passive Stretching
• Perception-Action Approach

Conditions studied

• Congenital Muscular Torticollis — all drugs for Congenital Muscular Torticollis →

Sponsor

Rosalind Franklin University of Medicine and Science

Who can join

Under 9 Months, any sex, with Congenital Muscular Torticollis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:

1. Still photography
2. Arthrodial goniometry used to assess active head rotation to both sides
3. The Muscle Function Scale (MFS) used to assess neck muscle strength
4. The Alberta Infant Motor Scale (AIMS) used to assess motor development
2. There will be no significant difference between the groups on the above listed measures after the intervention is completed.
3. 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
4. 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.