Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT07252713
- Status
- Recruiting
Conditions
- Cerebral Palsy (CP)
- Motor Delay
- Motor Disability
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 6 Years
- Healthy Volunteers
- Not accepted
Interventions
- Stander Use — BEHAVIORALThe 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.
Study Details
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
Key Dates
- Start date
- Feb 19, 2026
- Status verified
- May 2026
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Telehealth-delivered parent coaching intervention in adaptive stander useChildren 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.
Primary Outcome Measure
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. ]
Central Contacts
- Elizabeth Maus6148141279
- Petra Sternberg6145725446
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pediatric Assessment and Rehabilitation Lab | Columbus | Ohio | 43221 | Maus Elizabeth, DPT (PRINCIPAL_INVESTIGATOR) Sara Tafone, DPT (SUB_INVESTIGATOR) |
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