Stander Use for Motor Delay

(CP-MOVES Trial)

Overseen By Petra Sternberg

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Inability to participate in telehealth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to support young children with severe motor delays who cannot stand independently. The study tests whether using a special stander (a supportive device) at home, along with coaching via video calls, can improve children's physical activity, sleep, and endurance. It also examines whether this approach can reduce parental stress. Families with children aged 1-6 years who have significant motor challenges and internet access might be suitable candidates. Participants will use the stander three times a week for eight weeks and monitor changes in activity and well-being. As an unphased trial, this study provides families the chance to explore innovative support methods for their children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the use of adaptive standers is safe for children with severe motor delays?

Research has shown that adaptive standers, like those in this trial, are generally safe for children with movement difficulties. Studies have found that these devices can improve motor skills and increase walking speed in children with developmental delays. Doctors often recommend starting standing frames early to support normal motor development in children.

Although specific safety data is not detailed, the long-term use of standers in therapy suggests they are well-tolerated. Existing studies have reported no major negative effects, indicating that the adaptive standers used in this trial are likely safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to addressing motor delays in children using an adaptive stander. Unlike traditional therapies that often rely on in-person physical therapy sessions, this method incorporates telehealth to deliver parent coaching, which can make it more accessible and convenient for families. Additionally, the intervention is structured to be consistent with 30-minute sessions three times a week, potentially offering a more intensive and regular engagement than some other treatment options. This trial could pave the way for more flexible and effective ways to support children with motor delays.

What evidence suggests that using adaptive standers is effective for children with severe motor delays?

Research has shown that adaptive standers can help children with motor delays. One study found that standing can improve motor skills and help children with developmental delays walk faster. Healthcare experts recommend starting standing programs early to support normal motor development. Additionally, standing can enhance body functions like blood flow and digestion. Overall, these findings suggest that adaptive standers could increase physical activity and improve the quality of life for children with severe motor delays.

In this trial, participants will receive an adaptive stander and engage in telehealth-delivered parent coaching sessions to optimize stander use. ^{1 2 6 7 8}

Who Is on the Research Team?

Jill Heathcock, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for children aged 1-6 with severe motor delays, such as those unable to stand without support due to conditions like cerebral palsy. It also involves one parent of the child. The study excludes individuals who do not meet these specific age and condition requirements.

Inclusion Criteria

Parent willing and able to participate

Internet access for telehealth

Live within 100 miles of lab or willing to travel for device provision

Exclusion Criteria

Inability to participate in telehealth

My parent or caregiver cannot take part in this.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children complete three 30-minute sessions of standing in an adapted stander per week for 8 weeks. One session per week is telehealth-delivered with a physical therapist, and two sessions are completed as a home program with the parent and child.

8 weeks

1 telehealth visit per week, 2 home sessions per week

Follow-up

Participants are monitored for changes in physical activity, sleep, and endurance in children, and stress in parents, using wearable sensors and questionnaires.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stander Use

Trial Overview The CP-MOVES trial tests a telehealth-delivered, parent coaching program using adaptive standers to improve physical activity, sleep, and endurance in young children with motor delays. Parents' stress levels are also monitored. Children will use a stander three times weekly for eight weeks.

How Is the Trial Designed?

Group I: Telehealth-delivered parent coaching intervention in adaptive stander use Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Physical Therapy Association

Collaborator

Trials

16

Recruited

790+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11203597/

Supported Standing and Supported Stepping Devices for ... A small increase in walking speed was measured for children with developmental delays, and improved motor skills were measured for children at GMFCS levels I or ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cch.13320

Healthcare Professionals' Perspectives on the Use of ... The healthcare professionals' recommendation to start as early as possible with standing frames was based on imitating children's normal motor ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7439229/

3-Arm Randomized Clinical Trial Protocol - PubMed Central The primary purpose of this study is to evaluate the effect of SPEEDI on developmental outcomes measured on the Bayley Scales of Infant and Toddler Development, ...

4. rehabpub.com rehabpub.com/conditions/neurological/cerebral-palsy/the-need-to-stand/

The Need to Stand - Rehab Management Standing has been shown to improve circulatory, gastrointestinal, bowel control, and respiratory functions.

5. researchgate.net researchgate.net/publication/51523616_A_systematic_review_of_supported_standing_programs

(PDF) A systematic review of supported standing programs This systematic review investigated the available evidence underlying supported standing use based on the Center for Evidence-Based Medicine (CEBM) Levels of ...

6. publications.aap.org publications.aap.org/pediatrics/article/131/6/e2016/31072/Motor-Delays-Early-Identification-and-Evaluation

Motor Delays: Early Identification and Evaluation | Pediatrics This clinical report reviews the motor evaluation of children and offers guidelines to the pediatrician regarding an approach to children who demonstrate motor ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05117827

Pediatric Powered Wheelchair Standing Devices: An ... The purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a PWSD in children who have neurodevelopmental ...

8. health.ny.gov health.ny.gov/community/infants_children/early_intervention/docs/guidelines_motor_disorders_assessment_and_intervention.pdf

report of the recommendations motor disorders Use original quantitative data for outcomes of interest and appropriate statistical analysis of results (or be a systematic synthesis of such data from ...