NCT07252713 · Ohio State University
Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments
(CP-MOVES)
What this study is about
The primary goal of CP-MOVES is to evaluate 1) the preliminary effectiveness 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.
View original scientific description
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: 1. Do measures of physiological fitness and sleep in children with severe motor delays (i.e., unable to stand without support) change after a therapist-directed, parent-delivered intervention using telehealth and adaptive standers? 2. Do parents report any changes in their child's endurance, participation, or quality of life OR parent stress following intervention? Children ages 1-6 years old with severe motor delay and one parent will: 1. Complete three 30 minute sessions of standing in an adapted stander per week for 8 weeks. One session per week will be completed with a physical therapist, delivered through telehealth and two sessions per week will be completed as a home program with the parent and child (no therapist or telehealth). 2. Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment. 3. Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment. 4. Complete an assessment of postural control before and after treatment. 5.
Interventions
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.
Primary outcome measures
Wearable sensor physical activity data: Vector Magnitude
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Wearable sensor physical activity data: Daily Activity Counts
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Wearable sensor physical activity data: Average Resting Heart Rate
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Wearable sensor physical activity data
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Sleep wearable sensor data: total sleep time
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Sleep wearable sensor data: Sleep Latency
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Sleep wearable sensor data: Sleep efficiency
Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Child age 1-6 years with CP or other severe motor delay (GMFCS IV-V);
- Unable to stand without external support;
- Parent willing and able to participate;
- Internet access for telehealth;
- Live within 50 miles of lab or willing to travel to OSU for pre and post testing and stander provision
- One parent is fluent in English.
Exclusion criteria
- Inability to participate in telehealth
- Parent/caregiver unable to participate
Where
- Columbus, Ohio
Collaborators
American Physical Therapy Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations