Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments (CP-MOVES)

The Ohio State University

Status: Not yet enrolling

Conditions: Motor Delay; Motor Disability; Cerebral Palsy (CP)

Treatments: Behavioral: Stander Use

Study type: Interventional

Funder types: Other

Identifiers

NCT07252713

STUDY20251878

Details and patient eligibility

About

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 we aim 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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 100 miles of lab or travel for device provision,
• One parent is fluent in English.

Exclusion criteria

• Inability to participate in telehealth
• Parent/caregiver unable to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Telehealth-delivered parent coaching intervention in adaptive stander use

Experimental group

Description:

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.

Treatment:

Behavioral: Stander Use