Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/9/2019 |
| Start Date: | August 4, 2016 |
| End Date: | September 2019 |
| Contact: | Mary Rahlin, PT, DHS, PCS |
| Email: | Mary.Rahlin@rosalindfranklin.edu |
| Phone: | 847-578-8766 |
Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial
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
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
This prospective longitudinal study will be a two-group, single-blind, pre-post-test design
randomized clinical trial (RCT). The purpose of this study will be two-fold:
1. To compare the efficacy of passive stretching and Perception-Action (P-A) Approach
interventions in improving postural alignment, symmetrical use of both sides of the body
during movement and play, and gross motor development in infants with congenital
muscular torticollis (CMT)
2. To compare therapy-related behavior in infants with CMT undergoing passive stretching
and P-A Approach interventions during physical therapy (PT) sessions
Within group comparisons will be made to assess change over time, and between group
comparisons will be made to compare the effects of the two interventions. Both interventions
are used in the clinic for infants with CMT but it is not known whether they are equally
effective or if one is more effective than the other.
Thirty-six consecutively enrolled infants with CMT will be randomly assigned to a Passive
Stretching group or a P-A Approach group using a blocked randomization procedure. Each infant
will attend 5 weekly 60-minute PT sessions, including the initial evaluation, 3 interventions
sessions, and a re-evaluation. The total duration of each participant's involvement in the
study will be approximately 1-2 months. At visits 1 and 5, each infant's habitual head
deviation from midline, active head rotation to both sides, neck muscle strength on both
sides, motor development, and symmetrical use both sides of the body for movement and play
will be assessed.
Participants' photos will be taken in a supine position and parts of the initial PT
evaluation and re-evaluation sessions will be video recorded for future analyses by an
assessor blind to the infants' group assignment. Such analyses will include still photography
measurements, assessment of motor development using the Alberta Infant Motor Scale (AIMS),
and assessment of symmetrical use of both sides of the body using the Functional Symmetry
Observation Scale (FSOS). Treating therapists will perform "live" active head rotation and
muscle strength measurements, for which assessor blinding will not be possible. In addition,
each infant's behavior exhibited during therapy will be assessed by the treating therapist at
intervention sessions 2-4. Results obtained from the two groups will be compared.
At the first PT visit, the treating therapist will conduct a PT evaluation, educate the
caregiver in proper positioning and benefits of tummy time, and provide intervention specific
to the infant's group assignment. For the Passive Stretching Group, intervention will include
caregiver instruction in passive stretching for lateral flexion and rotation of the neck,
with the parent practicing the techniques. For the P-A Approach Group, intervention will
include the interpretation of the infant's behavior for the caregiver while manual guidance
is provided to the infant. At 3 subsequent PT sessions, group-specific intervention and
continued caregiver instruction will be provided. Passive Stretching Group intervention
components will include passive stretching and associated strengthening activities. P-A
Approach Group intervention components will include environmental set-up and manual guidance.
At the final PT visit in the study, a PT re-evaluation will be conducted, followed by
group-specific intervention as needed.
Prior to initiating the RCT, a pilot study will be conducted to establish the intrarater,
test-retest or inter-rater reliability of the outcome measures, as appropriate. A total of 10
infants with CMT will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a Fidelity of
Intervention Checklist to ensure the treating therapists' adherence to the strategies
outlined as essential elements of each of the intervention approaches. In addition, during
the main study, intervention adherence will be assessed by tracking the participants'
attendance, the PT session length and frequency, and the total duration of each subject's
research participation.
randomized clinical trial (RCT). The purpose of this study will be two-fold:
1. To compare the efficacy of passive stretching and Perception-Action (P-A) Approach
interventions in improving postural alignment, symmetrical use of both sides of the body
during movement and play, and gross motor development in infants with congenital
muscular torticollis (CMT)
2. To compare therapy-related behavior in infants with CMT undergoing passive stretching
and P-A Approach interventions during physical therapy (PT) sessions
Within group comparisons will be made to assess change over time, and between group
comparisons will be made to compare the effects of the two interventions. Both interventions
are used in the clinic for infants with CMT but it is not known whether they are equally
effective or if one is more effective than the other.
Thirty-six consecutively enrolled infants with CMT will be randomly assigned to a Passive
Stretching group or a P-A Approach group using a blocked randomization procedure. Each infant
will attend 5 weekly 60-minute PT sessions, including the initial evaluation, 3 interventions
sessions, and a re-evaluation. The total duration of each participant's involvement in the
study will be approximately 1-2 months. At visits 1 and 5, each infant's habitual head
deviation from midline, active head rotation to both sides, neck muscle strength on both
sides, motor development, and symmetrical use both sides of the body for movement and play
will be assessed.
Participants' photos will be taken in a supine position and parts of the initial PT
evaluation and re-evaluation sessions will be video recorded for future analyses by an
assessor blind to the infants' group assignment. Such analyses will include still photography
measurements, assessment of motor development using the Alberta Infant Motor Scale (AIMS),
and assessment of symmetrical use of both sides of the body using the Functional Symmetry
Observation Scale (FSOS). Treating therapists will perform "live" active head rotation and
muscle strength measurements, for which assessor blinding will not be possible. In addition,
each infant's behavior exhibited during therapy will be assessed by the treating therapist at
intervention sessions 2-4. Results obtained from the two groups will be compared.
At the first PT visit, the treating therapist will conduct a PT evaluation, educate the
caregiver in proper positioning and benefits of tummy time, and provide intervention specific
to the infant's group assignment. For the Passive Stretching Group, intervention will include
caregiver instruction in passive stretching for lateral flexion and rotation of the neck,
with the parent practicing the techniques. For the P-A Approach Group, intervention will
include the interpretation of the infant's behavior for the caregiver while manual guidance
is provided to the infant. At 3 subsequent PT sessions, group-specific intervention and
continued caregiver instruction will be provided. Passive Stretching Group intervention
components will include passive stretching and associated strengthening activities. P-A
Approach Group intervention components will include environmental set-up and manual guidance.
At the final PT visit in the study, a PT re-evaluation will be conducted, followed by
group-specific intervention as needed.
Prior to initiating the RCT, a pilot study will be conducted to establish the intrarater,
test-retest or inter-rater reliability of the outcome measures, as appropriate. A total of 10
infants with CMT will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a Fidelity of
Intervention Checklist to ensure the treating therapists' adherence to the strategies
outlined as essential elements of each of the intervention approaches. In addition, during
the main study, intervention adherence will be assessed by tracking the participants'
attendance, the PT session length and frequency, and the total duration of each subject's
research participation.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- the child is found to meet the exclusion criteria at any time during the clinical
trial
We found this trial at
1
site
3020 Childrens way
San Diego, California 92123
San Diego, California 92123
(858) 576-1700
Principal Investigator: Nancy Haney, PT, MS
Phone: 585-966-5829
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
Click here to add this to my saved trials
