Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ohio State University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Wearable sensor physical activity data: Vector Magnitude
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Telehealth-delivered parent coaching intervention in adaptive stander use
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.
Intervention: Stander Use (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD)(before and after 8-week intervention)
- Segmental Assessment of Trunk Control (SATCO)(Before and after 8-week intervention)
- Reaching Assessment(During treatment weeks 1, 2, 7, 8)
- Parent Interview(within 2 weeks of end of 8 week treatment period)
- Parenting Sense of Competence Scale-Revised(Before and after 8-week intervention)
Investigators
Jill Heathcock
Director, PEARL Lab
Ohio State University