An interventional study of Stander Use in Cerebral Palsy (CP), Motor Disability and Motor Delay, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
The primary goal of CP-MOVES is to evaluate 1) the preliminary efficacy of a telehealth-delivered, parent coaching intervention in the use of adaptive standers, on physical activity, sleep, and endurance in young children with severe motor delays and 2) on physical activity, sedentary time, resting heart rate, and perceived stress in parents.
The main questions the study aims to answer include:
Children ages 1-6 years old with severe motor delay and one parent will:
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Exclusion Criteria:
Children will receive an adaptive stander and complete 30-minute sessions 3 times per week for 8 weeks. One session per week will be telehealth-delivered with a study researcher.
Behavioral: Stander Use
The intervention includes 8 weeks of adaptive standing training delivered via telehealth with PT parent-coaching (1 telehealth session/week + 2 parent-led practice sessions/week). Sessions are 30 minutes, 3x/ week. Participants are provided a stander, sized to their age and body size for use during the study.
Wearable sensor physical activity data: Vector Magnitude
Vector Magnitude is a measure of moderate to vigorous physical activity measured in G-Force units. To be measured pre/post in parent and child. Higher values indicate greater intensity of movement. Values range from 0 (sedentary) to very vigorous (\>9500). Expect increase in vector magnitude with intervention.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Wearable sensor physical activity data: Daily Activity Counts
Wearable sensor outcomes measured in parent and child. Daily Activity Counts are a measure of frequency and intensity of physical activity, converted from raw acceleration data to unitless count data. Measure of activity over the whole day (expressed in minutes from 0-1440 per day) and binned into Sedentary, Light or Moderate/Vigorous physical activity. Expect increase in light and/or moderate to vigorous physical activity following intervention.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Wearable sensor physical activity data: Average Resting Heart Rate
Wearable sensor outcomes measured in parent and child., Average resting heart rate, measure in beats per minute, provides a measure of cardiorespiratory fitness. Normative values range from 50-100 beats per minute (adults and children, slightly higher in infants) with lower values indicating better fitness. Exploratory, but anticipate improved fitness (therefore lower resting heart rate) with intervention.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Wearable sensor physical activity data
Wearable sensor outcomes measured in parent and child. Daily sedentary time, measured in minutes, quantifies the amount of time per day spent sitting, lying or otherwise stationary. Measured in minutes (range: 0-1440 per day). Less sedentary time is ideal. Expect less sedentary time following intervention.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Sleep wearable sensor data: total sleep time
Sleep data measured in child only. Total sleep time is the amount of time, in minutes, that the child is sleeping. Measured in minutes (0-1440 minutes per day). Normative range from children ages 1-6 years is 9-14 hours per day. Exploratory measure, expect sleep to stay the same or slightly increase with increased physical activity.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Sleep wearable sensor data: Sleep Latency
Sleep data measured in child only. Sleep latency is a measure of the time gap between when the child lays down at bedtime until they fall asleep, as measured by the wearable sensor. Sleep latency is measured in minutes (range: 0-1440 minutes in a single day). Exploratory, but expect sleep latency time to decrease.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Sleep wearable sensor data: Sleep efficiency
Sleep data measured in child only. Sleep efficiency is the proportion of time in bed that the child is asleep and is reported as a percentage (range 0-100%). Exploratory variable, but expect values to improve with intervention.
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD)
A parent report measured designs to collect data across 6 domains including Activities of daily living, positioning transferring and mobility, comfort and emotions, communication social interaction, health, and overall quality of life. There are a total of 37 questions and. The questionnaire takes between 30 and 40 minutes to complete using a paper or electronic form. Scores are converted to a 0-100 scale. Normative value for a child with non-ambulatory CP is around 55-60. Lower scores indicate better health related quality of life. Expect scores to decrease with intervention.
Time frame: before and after 8-week intervention
Young Child-Participation in Environment Measure (YC-PEM)
A parent report measure that provides detailed information about the child's participation home school and in the community. These activities are measured according to frequency, level of involvement, desire for change in child's level of participation, and environmental supports. The YC-PEM includes 28 items and is valid in children 0-5 years old. Score range is 0-76. Higher scores indicate better participation. Expect scores to increase (better participation) with intervention.
Time frame: Before and after 8-week treatment
The Early Activity Scale for Endurance (EASE)
Measures endurance during physical activity in children with cerebral palsy. Eleven questions are rated on a 5 point Likert scale with a higher total score (range 11-55) indicating higher endurance. Higher scores indicate better endurance. Expect increase in scores following intervention.
Time frame: Before and after 8 week treatment
Perceived Stress Scale-14 (PSS-14)
Parents rate their stress levels over the past month. Fourteen items are rated on a 5-point Likert scale; higher scores indicate greater perceived stress. Lower scores indicate less stress. Expect decrease in stress (and therefore decreased PSS-14 score) following intervention.
Time frame: Before and after 8-week treatment period
Segmental Assessment of Trunk Control (SATCO)
The Segmental Assessment of Trunk Control (SATCo) is a standardized observational assessment used with infants and children with neuromotor impairments, including cerebral palsy. The SATCo will evaluate the participants' ability to maintain upright trunk posture in sitting when external support is provided at progressively lower trunk segments. Trunk control is assessed across static, active, and reactive conditions, reflecting the child's ability to maintain alignment, control posture during voluntary head movement, and recover alignment following brief external perturbations. The SATCo yields an ordinal score representing the highest trunk segment at which control is demonstrated, with higher scores indicating more advanced trunk control. Higher levels of achieved control (i.e., maintaining alignment with support lowered further down the trunk) indicate better trunk function, so higher segmental scores reflect improved postural control.
Time frame: Before and after 8-week intervention
Reaching Assessment
The reaching activity will be collected during the weekly 30-minute telehealth with the therapist. This telehealth therapy session will be recorded, and within a 5-10-minute window, the therapist will direct the parent to elicit reaching during the play session with the child. The 5-10-minute reaching activity will be removed from the 30-minute recorded telehealth with a therapist. The trimmed data will be coded using the behavioral coding tool Datavyu.
Time frame: During treatment weeks 1, 2, 7, 8
Parent Interview
The virtual interview with the parent will be audio recorded and stored in our lab's protected data-sharing system on Microsoft Teams. The questions will explore parents' experiences during the 8-week telehealth program, focusing on barriers/facilitators and perceived self-efficacy in delivering the home program.
Time frame: within 2 weeks of end of 8 week treatment period
Parenting Sense of Competence Scale-Revised
Parents will also fill out the Parenting Sense of Competence-Revised (PSOC-R), which contains 16 items. There are 10 items on the Efficacy subscale and 6 items on Satisfaction. All items are rated on a 6-point Likert scale. Possible scores range from 10 to 60 for Efficacy and 6 to 36 for Satisfaction. High scores on the subscales indicate high self-efficacy and satisfaction. We expect the intervention, which involve parent coaching in standing skills, will increase PSOC-R scores.
Time frame: Before and after 8-week intervention
Plan to share: No — For this small pilot study we do not anticipate sharing results due to difficulty in maintaining subject confidentiality in a small pilot study.
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