Multi Sensory Stimulation And Priming (MuSSAP) in Infants (4-12 Months of Age) at Risk of Developing Unilateral Cerebral Palsy (uCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI)
研究概览
简要总结
A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And Priming (MuSSAP) training on improving manual ability in infants at risk of developing unilateral Cerebral Palsy.
详细描述
Rationale:
Unilateral Cerebral Palsy (uCP) results from early brain damage. In adults, brain damage in one side of the (pre) motor cortex is associated with functional problems in the contralateral side of the body and vice versa. This is related to extensive crossings of the descending corticospinal tracts connecting the central motor systems with the musculature of the extremities. However, during the first years of our lives, crossings of the corticospinal tracts are less defined and the motor system relies on both ipsi- and contralateral connections to control the extremities. In children with uCP the classical development and strengthening of the crossed connections of the corticospinal tracts might be hampered. Although reorganization with ipsilateral corticospinal tracts can mediate useful hand function, patients with the most favourable functional outcome retain crossed projections from the affected hemisphere. To facilitate maturation of the corticospinal tracts, it seems crucial to start early with intervention at the stage that the corticospinal tracts show high plasticity. Attention benefits from multisensory congruent signals, particularly if this congruency involves rhythmical similarity. Attention influences the sensitivity of neurons to detect sensory activity and the ability of neurons to detect sensory stimulation. Formation of neural pathways is facilitated by increasing activity in (new) functional neural circuits. During the multisensory stimulation, motor actions of both or one arm and hand will be provoked. In contrast to the functional training focused primarily on motor output, MuSSAP enhances motor learning by stimulating the perception-action loop. In this study, we propose to pilot test whether a new intervention; Multi Sensory Stimulation And Priming (MuSSAP) can be applied in clinical practice in infants 4-12 months of age with diagnosed unilateral cerebral damage having increased risk on the development of unilateral cerebral palsy.
Objective:
Primary objective: The following hypothesis will be tested: MuSSAP in infants 4-12 months of age with diagnosed unilateral cerebral damage, is a feasible protocol and results in an enhanced motor development as compared to Intensive Usual Care (Upper Limb).
Secondary Objective(s): Assessment of feasibility of the intervention: Can the MuSSAP intervention and procedures be successfully executed and delivered to the participants? Assessment of acceptability: Suitability of the intervention and the study procedures from the perspective of the participants. Determining effect sizes for a future full-scale randomized clinical trial and clinical relevance.
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
- None
入排标准
- 年龄范围
- 4 Months 至 10 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI)
时间窗: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
The HAI is intended to evaluate the quality of goal-directed manual actions in infants, 3-12 months of age, at risk of developing unilateral CP. The test procedure comprises a semi-structured video-recorded 10-15-min play session. HAI is intended to detect and quantify possible asymmetry between hands by providing scores for each hand separately (Each Hand sum Score (EaHS) (range 0-24)), and to provide a measure of bilateral hand use (Both Hands Measure (BoHM) (range 0-100)) with a higher score reflecting a better outcome.
Adherence based on total training time
时间窗: During 8 week intervention
Parents fill out a digital time registration form to assess intervention adherence every day. Adherence will be calculated by dividing the registrated total training time by total planned training time (28 hours).
次要结局
- Gross motor development as assessed by the Gross Motor Function Measure (GMFM)(T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops))
- Quality of life as assessed by the Infant and Toddler Quality of life Questionnaire (ITQOL)(T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops))
- Motor development as assessed by the Bayley Scales of Infant and Toddler Development - Third Edition (Dutch version) (Bayley-III-NL)(T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops))
- Reaction time of self-initiated goal-directed movement and attention as assessed by the Video Observation Attention Affected Hand (VOAAH)(During 8 week intervention)
