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

Trial Summary

What is the purpose of this trial?

The purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower extremity passive range of motion to answer the following research questions: 1. Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida? 2. Does a home standing program change the quality of functional movement in children with spina bifida? 3. Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains? 4. Does a home standing program change a child's health-related quality of life in children with spinal bifida? 5. Does a home standing program result in a change in gait velocity in children with Spina Bifida?

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 data supports the effectiveness of the treatment Altimate Medical EasyStand Bantam for spina bifida?

The clinical evaluation of spina bifida patients using a hip guidance orthosis showed improved ambulation and efficiency, suggesting that similar supportive devices like the EasyStand Bantam may also enhance mobility and reduce energy expenditure in spina bifida patients. ^{1 2 3 4 5}

How does the EasyStand Bantam treatment differ from other treatments 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 easily, which can help improve their autonomy and reduce the risk of fractures by promoting early standing and short immobilization times. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Prenatal predictors of motor function in children with open spina bifida: a retrospective cohort study. [2022]

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

A long-term review of severely disabled spina bifida patients using a reciprocal walking system. [2019]

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

Health outcomes among youths and adults with spina bifida. [2015]

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

Clinical evaluation of spina bifida patients using hip guidance orthosis. [2019]

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

Postural Stability in Children with High Sacral Level Spina Bifida: Deviations from a Control Group. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Current status of orthotic management of children with meningomyelocele]. [2006]

7. England 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. [2021]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Spina bifida and cerebral palsy. [2007]

10. England pubmed.ncbi.nlm.nih.gov

The development of equipment by the RCA. [2019]