Cerebral Palsy (CP), Motor Delay, Motor Disability
Conditions
Keywords
Assistive Device, Stander, Physical Activity, Sedentary, Parent, Physical Therapy, Rehabilitation, Digital Health, Telehealth, Wearable Sensors
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. 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
Interventions
BEHAVIORALStander 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.
Sponsors
Ohio State University
American Physical Therapy Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearable sensor physical activity data: Vector Magnitude | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD) | before and after 8-week intervention | 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. |
| Young Child-Participation in Environment Measure (YC-PEM) | Before and after 8-week treatment | 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. |
| The Early Activity Scale for Endurance (EASE) | Before and after 8 week treatment | 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. |
| Perceived Stress Scale-14 (PSS-14) | Before and after 8-week treatment period | 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. |
| Segmental Assessment of Trunk Control (SATCO) | Before and after 8-week intervention | 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. |
| Reaching Assessment | During treatment weeks 1, 2, 7, 8 | 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. |
| Parent Interview | within 2 weeks of end of 8 week treatment period | 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. |
| Parenting Sense of Competence Scale-Revised | Before and after 8-week intervention | 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. |
Countries
United States
Contacts
CONTACTElizabeth Maus
CONTACTPetra Sternberg
PRINCIPAL_INVESTIGATORJill Heathcock, PhD
Ohio State University
Outcome results
None listed