Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase
研究概览
简要总结
The purpose of this study is to determine the optimal treatment duration of a novel early mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of treatment; and to evaluate the clinical futility of this intervention compared to current rehabilitation practice.
详细描述
This study is a single-blind, randomized exploratory clinical trial with repeated assessments during a 24-week treatment phase and at three follow-up points over 12 months after treatment to track the developmental trajectory of participants' motor function. Gross motor ability will be compared to published percentile scores of motor function development in cerebral palsy (CP) to determine if the trajectory of predicted motor development is altered, and to outcomes of intensity-matched conventional treatment to determine if continued Phase III investigation is warranted.
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-36 months of age
- •Gross motor function below the 10th percentile for age [Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years].
- •Diagnosis of CP or neurological sign associated with CP (i.e. spasticity).
- •Ability to initiate pulling to stand at a surface [Score of 1 on gross motor function measure (GMFM) Item 52].
- •Cognitive ability to follow one-step commands.
排除标准
- •Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP.
- •General muscle hypotonia, without other neurological signs associated with CP.
- •Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps).
- •At or above the 50th percentile of GMFCS Level I.
- •History of surgery or injury to the lower extremities in the past 6 months.
研究组 & 干预措施
Conventional Therapy
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
干预措施: Conventional Therapy (Other)
Dynamic Supported Mobility
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
干预措施: Dynamic Supported Mobility (Other)
结局指标
主要结局
Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase
时间窗: Baseline and 12 weeks
Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.
次要结局
- Change in Postural Control(Baseline and 12 weeks)
- Change in Caregiver Satisfaction(Baseline and 12 weeks)
- Change in Child Engagement in Daily Life(Baseline and 12 weeks)
- Change in Postural Control(Baseline and 12 weeks)
- Change in Physical Activity(Weeks 0 and 12)
- Change in Caregiver Satisfaction(Baseline and 12 weeks)
- Change in Child Engagement in Daily Life(Baseline and 12 weeks)