Cerebral Palsy (CP)CP-MOVESNCT07252713
Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments
A study testing Stander Use in people with Cerebral Palsy (CP) and Motor Disability, run by Ohio State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Cerebral Palsy (CP), Motor Disability, Motor Delay
- What is being tested?
- Stander Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Inability to participate in telehealth
- Parent/caregiver unable to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pediatric Assessment and Rehabilitation Lab
Columbus, Ohio, 43221
Petra Sternberg, 6145725446, petra.sternberg@osumc.edu
Maus Elizabeth, DPT
About this study
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:
Read more
- 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?
- 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:
- 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).
- Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment.
- Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment.
- Complete an assessment of postural control before and after treatment.
- Complete an post-treatment interview
- Conditions
- Cerebral Palsy (CP), Motor Disability, Motor Delay
- Being tested
- Stander Use
- Keywords
- Assistive Device, Stander, Physical Activity, Sedentary, Parent, Physical Therapy, Rehabilitation, Digital Health, Telehealth, Wearable Sensors
- Medical subject headings
- Cerebral Palsy, Psychomotor Disorders, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stander UseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth-delivered parent coaching intervention in adaptive stander use | Experimental | 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. Receives: Behavioral: Stander Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start19 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
- Investigators
- Jill Heathcock, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252713
- Sponsor's protocol ID
- STUDY20251878
- Acronym
- CP-MOVES
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For this small pilot study we do not anticipate sharing results due to difficulty in maintaining subject confidentiality in a small pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments
- ClinicalTrials.gov ID
- NCT07252713
- Acronym / sponsor ID
- CP-MOVES / STUDY20251878
- Conditions
- Cerebral Palsy (CP), Motor Disability, Motor Delay
- Keywords
- Assistive Device, Stander, Physical Activity, Sedentary, Parent, Physical Therapy, Rehabilitation, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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:
- 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).
- Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment.
- Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment.
- Complete an assessment of postural control before and after treatment.
- Complete an post-treatment interview
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth-delivered parent coaching intervention in adaptive stander use | Experimental | Behavioral: Stander UseChildren 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to participate in telehealth
- Parent/caregiver unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stander UseThe 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. | Behavioural | Telehealth-delivered parent coaching intervention in adaptive stander use |
Primary outcome
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.
8 secondary outcomes
Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD)
Time frame: before and after 8-week intervention
Young Child-Participation in Environment Measure (YC-PEM)
Time frame: Before and after 8-week treatment
The Early Activity Scale for Endurance (EASE)
Time frame: Before and after 8 week treatment
Perceived Stress Scale-14 (PSS-14)
Time frame: Before and after 8-week treatment period
Segmental Assessment of Trunk Control (SATCO)
Time frame: Before and after 8-week intervention
Reaching Assessment
Time frame: During treatment weeks 1, 2, 7, 8
Parent Interview
Time frame: within 2 weeks of end of 8 week treatment period
Parenting Sense of Competence Scale-Revised
Time frame: Before and after 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill Heathcock, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stander Use in people with Cerebral Palsy (CP) and Motor Disability, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Maus (6148141279, elizabeth.maus@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.