A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Shlomit Aizik

 
 
 
 
 
 
Therapeutic Dance Intervention for Children with 
Cerebral Palsy 
 
NCT03681171 
 
June 2, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol 
This is a pilot study that is being conducted to evaluate the feasibility of the 
proposed intervention and to collect pilot data from up to 10 participants that will be 
used to design a subsequent larger study. Data from this study will be used to identify 
hypotheses to be tested and for estimating the means(s) and standard deviations of 
outcome measurements that will be used to conduct a power-based determination of a 
minimal, adequate sample size for the subsequent study.  
Aim 1 – To evaluate baseline anthropometric, physiological, psychological, and 
physical functioning in a sample of children with cerebral palsy.  
Aim 2 – To systematically measure for the ﬁrst time in children with cerebral 
palsy the effects of a short-term ballet intervention. We will recruit up to 10 boys and 
girls (ages 9-15) who have cerebral palsy and enroll them in a 7-week intervention, 
which will include three 60-minute sessions of therapeutic dance intervention (ballet) 
per week. We will measure: • Gait and physical functioning • Executive functions • Social 
and emotional functioning • Body composition • Bone density • CBC and lipid panel • 
Muscle strength • Habitual physical activity  
Aim 3 – To evaluate the feasibility of measuring the acute effects of a session 
from the therapeutic dance intervention on executive functions and enjoyment in 
children with cerebral palsy. We will measure executive functions before and after a 
single session of intervention. 
 
As this is a very small pilot study, we will not have a control or comparison group 
and will not use randomization. The study is pre and post intervention design, with an 
added follow-up assessment. In other words, prior to intervention, we will collect 
baseline measurements on the domains of interest. Then there will be an intervention 
period, which will be followed with a post-intervention assessment on the same 
outcomes. To study whether any potential improvements are maintained, we will have 
another assessment at a follow-up period after a brief phase of no intervention. It is our 
goal to eventually conduct a fully randomized clinical trial, but in this ﬁrst pilot study, the 
study design is appropriate to the goals of piloting the intervention and evaluating the 
feasibility and acceptability of the research procedures and intervention. 
 

 
 
 
Means and standard deviations at each assessment point will be provided for 
each outcome collected according to the measurement schedule. To evaluate impact of 
the intervention, degree of change between the pre-intervention and post intervention 
points will be measured. To determine if potential gains seen across the intervention 
period are maintained, degree of change between post-intervention and the follow-up 
assessment will be measured. For each type of comparison (pre/post, post/follow-up, 
and acute), means and standard deviation of the change score, as well as within-subject 
effect sizes will be calculated and presented. We will examine this data both for the 
group as a whole as well as for subgroups (younger, older participants).