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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorOhio State University

About this trial

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. Complete an post-treatment interview

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Inability to participate in telehealth

Parent/caregiver unable to participate

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Telehealth-delivered parent coaching intervention in adaptive stander useExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

American Physical Therapy Association

Collaborator