Purpose

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

Conditions

Eligibility

Eligible Ages
Between 1 Year and 6 Years
Eligible 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.

Recruiting Locations

Pediatric Assessment and Rehabilitation Lab
Columbus, Ohio 43221
Contact:
Petra Sternberg
6145725446
petra.sternberg@osumc.edu

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

Elizabeth Maus
6148141279
elizabeth.maus@osumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.