Harness-Based Mobility Intervention for Infants With Down Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Nicole Baumer, MD, MEd

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston University Charles River Campus

Disqualifiers: Mosaic Down syndrome, Heart disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction. This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS by testing the feasibility of harness systems with infants and families and identifying measures that will serve as primary outcome variables. Upon completion of this pilot project, necessary preliminary data and experience required for an in-home, high-impact clinical trial for infants with DS will have been obtained.

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 data supports the effectiveness of the treatment Harness-based Mobility Intervention for Infants With Down Syndrome?

Research shows that body-weight-supported (BWS) overground gait training can improve walking abilities in children with motor impairments, suggesting that similar harness-based systems might help infants with Down syndrome. Additionally, a study found that a portable body weight support system is feasible for in-home use, which could make it easier for families to use this treatment regularly.

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Is the harness-based mobility intervention safe for infants with Down syndrome?

The studies reviewed focus on the feasibility and acceptability of the harness-based mobility system for infants with Down syndrome, but they do not report any specific safety concerns or adverse effects related to its use.

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How is the harness-based mobility intervention treatment different from other treatments for infants with Down syndrome?

The harness-based mobility intervention is unique because it uses a portable body weight support system that allows infants with Down syndrome to practice moving at home, rather than in a clinic. This system supports early, high-dose, and varied movement, which can be managed by both professionals and parents, making it more accessible and practical for everyday use.

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Eligibility Criteria

This trial is for infants with Down syndrome to help them develop mobility skills like crawling and walking. It's designed to see if using a body weight supported harness can aid their movement, exploration, and social interaction.

Inclusion Criteria

English is the main language spoken in my home.

I can sit without help but cannot walk on my own.

I have been diagnosed with Down syndrome.

Exclusion Criteria

I have a specific type of Down syndrome.

I do not have severe, uncontrolled medical issues like unstable heart disease or epilepsy.

I have severe hearing or vision problems that cannot be corrected.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Harness Trial Period

Families use the body weight supported harness system with their infant for at least 30 minutes daily for one month. Investigators assist with setup and provide training.

4 weeks

1 visit (in-person) for setup and training

Observation

Participants are observed twice a month for 6 months, with one visit per month on Zoom and the other in person. Observations include videorecording of play sessions and administration of developmental assessments.

6 months

12 visits (6 in-person, 6 virtual)

Follow-up

Participants are monitored for safety and effectiveness after the harness trial period, including surveys on feasibility and satisfaction.

4 weeks

Participant Groups

The study is testing the use of a special harness that supports an infant's body weight. This may help infants with Down syndrome move more easily, which could lead to better learning opportunities through exploration and interaction.

Group I: Body weight supported harness Experimental Treatment 1 Intervention

Harness is set up in families' homes for one month. Caregivers re asked to use the harness with their infant for 30 min/day, 5 times a week.

Harness-based Mobility Intervention is already approved in United States for the following indications:

🇺🇸 Approved in United States as Harness-based Mobility Intervention for:

• Mobility assistance for infants with Down syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston University Boston, MA

Who Is Running the Clinical Trial?

Boston University Charles River Campus Lead Sponsor

Boston Children's Hospital Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

In-Home Mobility Training With a Portable Body Weight Support System of an Infant With Down Syndrome. [2021] To report on the feasibility of an open-area, portable body weight support system (PBWSS) for in-home use and overground mobility training in an infant with Down syndrome.

2. England pubmed.ncbi.nlm.nih.gov

User-centred assistive technology assessment of a portable open-area body weight support system for in-home use. [2021] Current paediatric technology lacks mobility devices that support early, high-dose and variable movement that can be managed by professionals and parents outside of the lab or clinic. Parent acceptability of the technology is a critical piece to the continued use of devices by their infants. The purpose of this study was to determine the level of feasibility of an in-home application of a novel portable body weight support system (PBWSS), designed for community use.

3. England pubmed.ncbi.nlm.nih.gov

Overground body-weight-supported gait training for children and youth with neuromuscular impairments. [2013] The aim of this investigation was to determine if body-weight-supported (BWS) overground gait training has the potential to improve the walking abilities of children and youth with childhood onset motor impairments and intellectual disabilities. Eight participants (mean age of 16.3 years) completed 12 weeks of BWS overground gait training that was performed two times a week. BWS was provided during the training sessions by an overhead harness system that rolls overground. There was a significant improvement in the preferred walking speed after the training (p

4. England pubmed.ncbi.nlm.nih.gov

Treadmill training with partial body-weight support in children with cerebral palsy: a systematic review. [2022] The aim of this systematic review was to examine the literature on the effects of partial body-weight support treadmill training (PBWSTT) in children with cerebral palsy (CP) on functional outcomes and attainment of ambulation.

5. England pubmed.ncbi.nlm.nih.gov

The use and perception of support walkers for children with disabilities: a United Kingdom survey. [2022] Support walkers are a type of assistive device that may enable non-ambulant children with disabilities to walk independently and promote improvements in bowel function, bone mineral density (BMD), mobility, independence, participation and social function. However, there is little evidence to support these benefits and there is a lack of research describing the use of support walkers in clinical practice. This study aimed to examine the use of support walkers for children with disabilities in clinical practice.

6. England pubmed.ncbi.nlm.nih.gov

MIT-Skywalker: considerations on the Design of a Body Weight Support System. [2018] To provide body weight support during walking and balance training, one can employ two distinct embodiments: support through a harness hanging from an overhead system or support through a saddle/seat type. This paper presents a comparison of these two approaches. Ultimately, this comparison determined our selection of the body weight support system employed in the MIT-Skywalker, a robotic device developed for the rehabilitation/habilitation of gait and balance after a neurological injury.

7. United States pubmed.ncbi.nlm.nih.gov

The Reasons and Associated Injuries Related to Baby Walkers Use Among Children in Riyadh, Saudi Arabia. [2023] Baby walkers (BW) are devices commonly used for helping babies' mobility. However, it is associated with different types of injuries. Parents still use BWs and believe that it promotes early walking.

8. Australia pubmed.ncbi.nlm.nih.gov

Contact pressure distribution features in Down syndrome infants in supine and prone positions, analyzed by photoelastic methods. [2016] Local force distribution supporting the bodyweight of infants with Down syndrome (DS) appears to be different from that of healthy controls. The purpose of the present study was to establish methods to assess this force distribution and to allow therapeutic evaluation of neurological development in DS infants prior to walking.