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Recruiting NCT07252713

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

No phase Interventional Cerebral Palsy (CP) Motor Disability Motor Delay

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stander Use.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP), Motor Disability, Motor Delay. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Stander 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.

Primary outcome measures

  • 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.]
  • 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 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 physical activity data [Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • 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 wearable sensor data: Sleep Latency [Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Sleep wearable sensor data: Sleep efficiency [Time frame: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Pediatric Assessment and Rehabilitation Lab — Columbus

Identifiers

NCT: NCT07252713 · STUDY20251878

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗