Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Still Photography
研究概览
简要总结
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:
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There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:
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Still photography
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Arthrodial goniometry used to assess active head rotation to both sides
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The Muscle Function Scale (MFS) used to assess neck muscle strength
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The Alberta Infant Motor Scale (AIMS) used to assess motor development
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There will be no significant difference between the groups on the above listed measures after the intervention is completed.
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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
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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
详细描述
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:
- 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)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Still Photography
时间窗: At baseline and week 5
Change in the angle of habitual head deviation from midline assessed in a supine position
Alberta Infant Motor Scale (AIMS)
时间窗: At baseline and week 5
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
Arthrodial Goniometry
时间窗: At baseline and week 5
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Muscle Function Scale (MFS)
时间窗: At baseline and week 5
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
Functional Symmetry Observation Scale (FSOS)
时间窗: At baseline and week 5
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
次要结局
- Therapy Behavior Scale (TBS)(Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4))
研究者
Mary Rahlin
Associate Professor
Rosalind Franklin University of Medicine and Science