Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments

NCT07252713 | Recruiting

• 1 other identifier: STUDY20251878
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 perceived stress in parents. The main questions the study aims to answer include:

1. 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. 2.Do parents report any changes in their child's endurance, participation, or quality of life OR parent stress following intervention?
3. 3.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).
4. 4.Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment.
5. 5.Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment.

Conditions

Cerebral Palsy (CP); Motor Disability; Motor Delay

Keywords

Assistive Device; Stander; Physical Activity; Sedentary; Parent; Physical Therapy; Rehabilitation; Digital Health; Telehealth; Wearable Sensors

Outcome Measures

Primary Outcomes (7)

• 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.

  From enrollment to end of 8-week treatment period

• 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.

  From enrollment to end of 8-week treatment period

• 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.

  From enrollment to end of 8-week treatment period

• 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.

  From enrollment to end of 8-week treatment period

• 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.

  From enrollment until end of treatment period ( 8 weeks)

• 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.

  From enrollment until end of treatment period ( 8 weeks)

• 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.

  From enrollment until end of treatment period ( 8 weeks)

Secondary Outcomes (4)

• Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD)

  before and after 8-week intervention

• Young Child-Participation in Environment Measure (YC-PEM)

  Before and after 8-week treatment

• The Early Activity Scale for Endurance (EASE)

  Before and after 8 week treatment

• Perceived Stress Scale-14 (PSS-14)

  Before and after 8-week treatment period

Study Arms (1)

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.

Behavioral: Stander Use

Interventions

Stander Use BEHAVIORAL

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.

Telehealth-delivered parent coaching intervention in adaptive stander use

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 100 miles of lab or travel for device provision,
• One parent is fluent in English.

You may not qualify if:

• Inability to participate in telehealth
• Parent/caregiver unable to participate

Sponsors & Collaborators

• Ohio State University: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

Pediatric Assessment and Rehabilitation Lab

Columbus, Ohio, 43221, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Psychomotor Disorders; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jill Heathcock, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Maus

CONTACT

6148141279; elizabeth.maus@osumc.edu

Petra Sternberg

CONTACT

6145725446; petra.sternberg@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, PEARL Lab

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 28, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-02

Locations

US (1)