Recruiting

Telehealth Intervention

Sponsor:

Ohio State University

Code:

NCT07252713

Conditions

Cerebral Palsy (CP)

Motor Disability

Motor Delay

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

Interventions

Stander Use

Study Details

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

Conditions

Cerebral Palsy (CP)

Motor Disability

Motor Delay

Study ID

NCT07252713

Start date

Feb 19, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Elizabeth Maus

6148141279elizabeth.maus@osumc.edu

Petra Sternberg

6145725446petra.sternberg@osumc.edu

Locations

Pediatric Assessment and Rehabilitation Lab

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Petra Sternberg

6145725446petra.sternberg@osumc.edu

Principal Investigator:

Maus Elizabeth, DPT

More Information

Sponsor

Ohio State University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Assistive Device
  • Stander
  • Physical Activity
  • Sedentary
  • Parent
  • Physical Therapy
  • Rehabilitation
  • Digital Health
  • Telehealth
  • Wearable Sensors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-07.