跳至主要内容
临床试验/NCT04997109
NCT04997109招募中不适用

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Emory University8 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2022年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
267
试验地点
8
主要终点
Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score

研究概览

简要总结

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

详细描述

Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another ~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.

Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.

Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.

Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.

In this study, infant participants with CP will be randomized to one of three treatment groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Months 至 13 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 4 to 13 months, corrected age
  • Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)
  • Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
  • Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1
  • Parent/legal guardian is able to provide informed consent

排除标准

  • Congenital malformation of the brain or musculoskeletal system (MSK)
  • Receipt of botulinum toxin to the affected extremity within 3 months of study entry
  • Any prior long-term hard constraint programs

结局指标

主要结局

Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score

时间窗: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.

Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score

时间窗: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.

次要结局

  • Change in Infant Motor Activity Log (IMAL) How Often Score(Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention))
  • Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score(Baseline, Week 6 (after the first intervention))
  • Change in Welch Emotional Connection Screen (WECS) Score(Baseline, Week 6 (after the first intervention))
  • Change in Hand Assessment in Infants (HAI) Score(Baseline, Week 6 (after the first intervention))
  • Change in Maternal Confidence Questionnaire (MCQ) Score(Baseline, Week 6 (after the first intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathalie Maitre

Professor

Emory University

研究点 (8)

Loading locations...

相似试验