Standing Program for Spina Bifida

Overseen By Marianne Hanover, DPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of St. Augustine for Health Sciences

Disqualifiers: Non-MMC SB, Hoffer level 5, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home standing program can improve movement and quality of life for children with Spina Bifida, a condition affecting spinal development. Researchers aim to determine if this program can reduce joint stiffness, improve daily activities, and enhance walking speed. The study uses a special device called the Altimate Medical EasyStand Bantam to assist with standing exercises at home. Children aged 5 to 12 who can walk 10 meters and do not have severe health restrictions are eligible to participate. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their mobility and daily life activities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Altimate Medical EasyStand Bantam is safe for children with Spina Bifida?

Research shows that standing programs, such as those using the EasyStand Bantam device, are generally safe for children with spina bifida. Studies have found that these personalized programs can improve muscle flexibility and movement. They enable children to transition from sitting to standing, enhancing their range of motion and other physical abilities.

Although the specific trial for the EasyStand Bantam lacks detailed safety data, the device is designed with safety in mind. Past research and user feedback indicate that these standing programs are well-tolerated, with no serious side effects commonly reported. Overall, existing evidence suggests that these programs are safe and can help children with spina bifida improve their physical function and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Standing Program for Spina Bifida because it explores how a structured standing routine at home might improve the quality of life for children with this condition. Unlike traditional treatments that focus on surgery or assistive devices, this program emphasizes consistent engagement in standing activities, which could enhance functional movement and gait velocity. By systematically alternating between baseline and intervention phases, the program aims to provide insights into the potential benefits of regular standing, potentially offering a non-invasive and empowering approach to managing spina bifida.

What evidence suggests that this standing program is effective for Spina Bifida?

Research has shown that standing programs can improve muscle flexibility and movement in children with spina bifida. Studies indicate that these programs may reduce leg stiffness, making movement easier for children. In this trial, the EasyStand Bantam is part of the standing program intervention, allowing children to switch between sitting and standing, which can enhance mobility. Some evidence also suggests that standing can strengthen bones and reduce muscle tightness. Overall, these programs aim to ease daily activities and potentially improve the quality of life for children with spina bifida. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for children with Spina Bifida who have significant knee limitations. It aims to see if a home standing program can improve their movement, daily activities, social and cognitive skills, quality of life, and walking speed.

Inclusion Criteria

I can move my legs fully without medical restrictions.

I am between 5 and 12 years old.

I can lay flat on my back for tests.

Exclusion Criteria

I have a condition unrelated to MMC that affects my ability to stand.

I cannot walk on my own due to my condition.

I cannot stand due to medical conditions like severe osteoporosis or heart/lung issues.

Timeline for a Trial Participant

Reliability Stage

Children are assessed by two study investigators in two different sessions on the same day to determine intrarater and interrater reliability.

1 day

2 visits (in-person)

Intervention Stage

A single-subject study ABABA design with alternating baseline and intervention phases to assess the effectiveness of a home standing program.

28 weeks

Biweekly visits (in-person)

Follow-up

Participants are monitored for changes in functional movement, performance in daily activities, and health-related quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Altimate Medical EasyStand Bantam

Trial Overview The study tests the EasyStand Bantam device in a single-subject design to evaluate its impact on children with Spina Bifida. Researchers want to know if using this device at home can help these kids move better and enhance their overall well-being.

How Is the Trial Designed?

Group I: Standing Program Intervention Experimental Treatment 1 Intervention

A single-subject study ABABA design will be used with dependent variables of passive range of motion, functional movement, functional skills performance, engagement, health related quality of life and gait velocity will be recorded repeatedly for the individual participants across time and with systematic manipulation of the independent variable, which is the standing home program intervention. The study will span 28 weeks for the intervention Stage 2, consisting of three baseline phases (A) of four weeks each and two home program intervention phases (B) of eight weeks each that alternate in an ABABA design.

Group II: Reliability Active Control 1 Intervention

Children will be assessed by two study investigators in two different sessions on the same day, with a washout period of 3 hours between sessions. Intrarater reliability will be determined by comparing rater's scores for each child. These sessions will include goniometric measurements of lower extremity passive range of motion and the 10-Meter Walk Test. Children will have the opportunity to rest or resume normal activities with a minimum of 3 hours between sessions. Interrater reliability will be determined based on the measurements in the same session by 2 different raters.

Altimate Medical EasyStand Bantam is already approved in United States, European Union, Canada for the following indications:

Approved in United States as EasyStand Bantam for:

• Spina bifida
• Lower extremity passive range of motion limitations
• Mobility assistance

Approved in European Union as EasyStand Bantam for:

• Spina bifida
• Orthopedic rehabilitation
• Mobility assistance

Approved in Canada as EasyStand Bantam for:

• Spina bifida
• Lower extremity passive range of motion limitations
• Mobility assistance

Who Is Running the Clinical Trial?

University of St. Augustine for Health Sciences

Lead Sponsor

Trials

8

Recruited

450+

Published Research Related to This Trial

In a study of 127 patients with open spina bifida, intact motor function (MF) detected via ultrasound during pregnancy was a strong predictor of maintaining MF at birth and at 12 months for those who underwent prenatal repair.

For postnatally repaired patients, the only significant predictor of intact MF at 12 months was having intact MF at birth, highlighting the importance of early motor function assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal predictors of motor function in children with open spina bifida: a retrospective cohort study. Corroenne, R., Yepez, M., Pyarali, M., et al.[2022]

Orthotic devices for children with Spina bifida can significantly improve their autonomy in standing and walking, but their effectiveness depends on considering the child's overall development and current situation.

To ensure optimal acceptance and integration of these devices into daily activities, it is crucial that children experience the benefits of reduced effort in standing and walking when using the orthoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current status of orthotic management of children with meningomyelocele]. Doll, B., Michael, T.[2006]

A new posture and mobility test has been successfully applied to children with spina bifida, demonstrating that their gross motor skills can be quantitatively assessed.

Children with both spina bifida and hemiplegic cerebral palsy showed significantly lower posture and mobility scores compared to those with only one of the conditions, indicating a compounded effect on motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spina bifida and cerebral palsy. Minns, RA., Hazelwood, E., Brown, JK., et al.[2007]

The Royal College of Art team has developed specialized equipment, including a combined toilet and shower seat and a height-adjustable dressing/treatment bench, specifically designed for children with spina bifida.

These standard items aim to improve the daily living and treatment experiences for children with spina bifida, with plans for further developments to enhance their usability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of equipment by the RCA. Matthiessen, C.[2019]

Sit-to-stand exercise programs have moderate-quality evidence showing they can improve sit-to-stand performance in patients with physical impairments, particularly those with neurological conditions, based on a review of eight randomized controlled trials.

However, the same training did not show improvements in balance, gait speed, distance, lower limb muscle strength, or participation, suggesting that while beneficial for sit-to-stand function, it may not enhance other physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sit-to-stand exercise programs improve sit-to-stand performance in people with physical impairments due to health conditions: a systematic review and meta-analysis. Chaovalit, S., Taylor, NF., Dodd, KJ.[2021]

The hip guidance orthosis significantly improves ambulation in children with myelomeningocele, with 13 out of 27 patients showing improved walking ability and most others demonstrating measurable benefits after using the device for 6 to 45 months.

Patients experienced an average increase in walking speed of 87.3% and a decrease in heart rate by 10 bpm, indicating enhanced efficiency and lower energy expenditure during ambulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of spina bifida patients using hip guidance orthosis. Rose, GK., Stallard, J., Sankarankutty, M.[2019]

Children with spina bifida cystica have a high fracture risk (12.2%) due to reduced muscle activity in their paralyzed legs, particularly after orthopedic surgeries and during cast immobilization.

Fractures in these children heal faster than in non-paralyzed children, and using standing casts can help maintain axial loading, which is crucial for preventing further fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Origin and treatment of fractures in spina bifida. Parsch, K.[2022]

Children with high sacral level spina bifida showed significantly poorer static and dynamic postural stability compared to healthy controls, indicating that even those with less severe forms of the condition experience balance challenges.

Lower ankle muscle strength was found to negatively impact postural stability, suggesting that strengthening ankle muscles could be a key focus for improving balance in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural Stability in Children with High Sacral Level Spina Bifida: Deviations from a Control Group. Gencer-Atalay, K., Karadag-Saygi, E., Mirzayeva, S., et al.[2021]

The study followed 28 pediatric spina bifida patients using the Parawalker reciprocal walking orthosis for an average of 9.71 years, demonstrating long-term compliance and effective ambulation without any reported pressure sores or bone fractures.

The findings suggest that a comprehensive healthcare approach can enhance patient function and lead to cost savings by reducing complications associated with immobility, such as pressure sores and fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A long-term review of severely disabled spina bifida patients using a reciprocal walking system. Roussos, N., Patrick, JH., Hodnett, C., et al.[2019]

Youths with spina bifida generally reported better self-rated health, with 65% rating their health as excellent or very good, compared to only 23% of young adults, indicating a decline in perceived health as they age.

The health-related quality of life (HR-QoL) scores were significantly lower for young adults (mean score 0.36) compared to youths (mean score 0.57) on the Health Utilities Index Mark 3, highlighting a gap between personal health perceptions and standardized HR-QoL measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health outcomes among youths and adults with spina bifida. Young, NL., Sheridan, K., Burke, TA., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06419049

Impact of Standing Programs in Children With Spina Bifida ... The purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12525406/

Effects of a Standing Program for Ambulatory Children with ... Conclusions: Personalized standing programs may improve muscle flexibility and functional movement quality in ambulatory children with MMC.

3. withpower.com withpower.com/trial/phase-spinal-dysraphism-1-2023-8d563

Standing Program for Spina Bifida The EasyStand Bantam is unique because it combines standing and sitting functions, allowing children with spina bifida to transition between these positions ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5533185/

Factors Associated with Mobility Outcomes in a National ... To provide descriptive data on ambulatory ability and muscle strength in a large cohort of individuals with spina bifida enrolled in a National Spina Bifida ...

5. easystand.com easystand.com/2016/04/systematic-review-supported-standing-programs/

A systematic review of supported standing programs The data were moderately strong for the use of supported standing for BMD increase, showed some support for decreasing hypertonicity (including ...

6. altimatemedical.com altimatemedical.com/wp-content/IFU/IFU-EN-English.pdf

Instructions For Use Manual Please ensure this ... The EasyStand Evolv, Glider & StrapStand products are intended to assist individuals who have difficulty rising from a seated position to a standing position.