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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy (CP) Motor Disability Motor Delay

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stander Use

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.