Harness-Based Mobility Intervention for Infants With Down Syndrome

Overseen By Anna Donato

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Mosaic Down syndrome, Heart disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help infants with Down syndrome move around more independently. Researchers are testing a special harness system that supports a baby's weight, potentially helping them crawl and walk sooner. The goal is to determine if using the harness at home encourages exploration, communication, and social interaction. It suits families with infants under 24 months who can sit without assistance but aren't yet walking independently, and who speak English at home. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance early development in infants with Down syndrome.

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 this harness-based mobility intervention is safe for infants with Down syndrome?

Research has shown that harness-based mobility systems are safe and easy to use. One study found that these harnesses do not alter the body's natural weight distribution or movement, ensuring they are gentle and do not strain infants. Another study found that using these harnesses at home is safe and encourages children with certain conditions to exercise more. Designed to support infants and facilitate movement without harm, these harnesses have no reported serious side effects or injuries, suggesting they are a safe option for infants with Down syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapies for infants with Down syndrome that often focus on direct physical therapy exercises, the harness-based mobility intervention offers a novel approach by allowing infants to experience self-initiated movement. This method involves using a body weight-supported harness set up in the home, which encourages natural movement and exploration in a familiar environment. Researchers are excited about this treatment because it empowers caregivers to actively participate in their child's development and has the potential to enhance motor skills through consistent, daily practice.

What evidence suggests that this harness-based mobility intervention is effective for infants with Down syndrome?

Research shows that a special harness, which participants in this trial will use, can help infants with Down syndrome move more and explore their surroundings. This exploration may enhance their communication and social skills, crucial for early learning. Studies have found these harness systems to be safe and suitable for home use. They have also assisted with exercise and movement in other conditions, such as spinal muscular atrophy (SMA). Although data specifically for infants with Down syndrome is limited, the harnesses could offer similar benefits by supporting their movement development. ^{1 2 4 6 7}

Who Is on the Research Team?

Jana Iverson, PhD

Principal Investigator

Boston University

Nicole Baumer, MD, MEd

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Harness-based Mobility Intervention

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

A novel portable body weight support system (PBWSS) was successfully used by 16 infants in both home and lab settings, with parents reporting positive behavioral changes in their infants, including the initiation of new movements.

Parents found the device easy to set up and use, expressed satisfaction with its design, and suggested improvements for comfort, indicating strong acceptability and potential for ongoing use in promoting mobility in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centred assistive technology assessment of a portable open-area body weight support system for in-home use. Kokkoni, E., Galloway, JC.[2021]

A 12-week study involving 8 participants with childhood onset motor impairments showed that body-weight-supported (BWS) overground gait training significantly improved walking speed and cadence.

After the training, participants' preferred walking speed increased from 0.51 m/s to 0.67 m/s, and their cadence improved from 37 steps/min to 43 steps/min, indicating that BWS gait training can effectively enhance walking abilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground body-weight-supported gait training for children and youth with neuromuscular impairments. Kurz, MJ., Stuberg, W., Dejong, S., et al.[2013]

A systematic review of eight studies involving 41 children with cerebral palsy found limited evidence supporting the effectiveness of partial body-weight support treadmill training (PBWSTT) on functional outcomes, with many studies not demonstrating statistical significance despite some reported improvements.

The review highlighted significant limitations, including a small sample size and varying abilities among participants, indicating that more rigorous randomized controlled trials are necessary to assess the true efficacy of PBWSTT for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training with partial body-weight support in children with cerebral palsy: a systematic review. Mutlu, A., Krosschell, K., Spira, DG.[2022]

The portable body weight support system (PBWSS) was used effectively by a family for an average of 4 days a week, helping an infant with Down syndrome improve her mobility during training sessions.

Frequent use of the PBWSS allowed the infant to practice motor skills in a natural environment, suggesting that this method could positively influence her overall development, although more research with larger samples is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Home Mobility Training With a Portable Body Weight Support System of an Infant With Down Syndrome. Kokkoni, E., Stoner, T., Galloway, JC.[2021]

In a study involving eight healthy subjects, the saddle/seat support system provided better stability during walking, showing higher mediolateral trunk inclination compared to the overhead harness system, which was more stable but less effective for balance training.

The saddle/seat system was chosen for the MIT-Skywalker robotic device because it allows for quicker adjustments, better patient centering on the treadmill, and supports a wider range of training activities, making it more versatile for rehabilitation after neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MIT-Skywalker: considerations on the Design of a Body Weight Support System. Gonçalves, RS., Krebs, HI.[2018]

In a study of 977 families in Riyadh, Saudi Arabia, 78.3% reported using baby walkers, primarily believing they help babies walk earlier, despite 15% of users experiencing injuries, mostly from falls.

There is a significant lack of awareness about the risks associated with baby walkers, with only 5.1% of users recognizing the dangers, highlighting the need for increased education and potential regulation on their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reasons and Associated Injuries Related to Baby Walkers Use Among Children in Riyadh, Saudi Arabia. Albarrak, YA., Algwaiz, AF., Sharaf, AM., et al.[2023]

A survey of 125 professionals involved with children who have disabilities revealed that support walkers are commonly prescribed and used, with reported benefits including increased physical activity and enjoyment for children aged 6 months to 18 years.

Despite some challenges like space limitations and transfer difficulties, the findings highlight the need for further research to establish consistent clinical practices and to evaluate the effectiveness of support walkers in improving mobility and overall function in children with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use and perception of support walkers for children with disabilities: a United Kingdom survey. George, C., Levin, W., Ryan, JM.[2022]

Infants with Down syndrome (DS) show different local force distribution patterns when supporting their body weight compared to healthy controls, indicating potential developmental differences in weight-bearing abilities.

The study found that while healthy infants showed a decrease in head loading ratio as they aged, DS infants had a lesser decrease, suggesting poorer coordinated development of weight-supporting limbs, which could impact their neurological development before walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact pressure distribution features in Down syndrome infants in supine and prone positions, analyzed by photoelastic methods. Nishizawa, Y., Fujita, T., Matsuoka, K., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06219863

Harness-based Mobility Intervention for Infants With Down ... Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06219863/harness-based-mobility-intervention-for-infants-with-down-syndrome

Harness-based Mobility Intervention for Infants With Down ... This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS.

3. bu.trialstoday.org bu.trialstoday.org/trial/NCT06219863

Harness-based Mobility Intervention for Infants With Down ... Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39073058/

Exploring the Efficacy of a Dynamic Harness System on ... Exploring the Efficacy of a Dynamic Harness System on Gross Motor Development and Motivation for Infants With Down Syndrome: A Pilot Study.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0300244

Feasibility and utility of in-home body weight support harness ... Use of in-home BWSS is a safe, feasible and useful option to increase exercise dosage after treatment in SMA and may help optimize motor abilities.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7580661/

Design and Validation of a Low-Cost Bodyweight Support ... These harness-based bodyweight support systems do not alter the weight or inertial properties of the individual body segments. Bodyweight supported gait ...

7. mdpi.com mdpi.com/1648-9144/61/7/1125

Comparative Effects of Partial Body Weight-Supported and ... This study indicates that PBWSTT and LTT can improve gait parameters in children with CP, with PBWSTT promoting postural control and LTT improving mobility.