Standing Program for Spina Bifida
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of St. Augustine for Health Sciences
Disqualifiers: Non-MMC SB, Hoffer level 5, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345How 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.
678910Eligibility 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.
+1 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standing Program InterventionExperimental Treatment1 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: ReliabilityActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of St. AugustineSan Diego, CA
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Who Is Running the Clinical Trial?
University of St. Augustine for Health SciencesLead Sponsor
References
Prenatal predictors of motor function in children with open spina bifida: a retrospective cohort study. [2022]To identify predictors for intact motor function (MF) at birth and at 12 months of life in babies with prenatally versus postnatally repaired open spina bifida (OSB).
A long-term review of severely disabled spina bifida patients using a reciprocal walking system. [2019]The purpose of the study was to establish long-term compliance of paediatric spina bifida patients using a reciprocal walking orthosis, prescribed to enhance function and long-term therapeutic benefit.
Health outcomes among youths and adults with spina bifida. [2015]To describe the health and health-related quality of life (HR-QoL) outcomes of youths and young adults with spina bifida.
Clinical evaluation of spina bifida patients using hip guidance orthosis. [2019]A hip guidance orthosis has been designed to provide the highest potential level of ambulation for the child with myelomeningocele. It permits low energy-cost ambulation at a reasonable speed, and independent transfer from chair to walking and vice versa. It also enables some patients to ascend or descend steps of up to 150mm, as well as gradients of up to one in 10. A review of 27 patients who had used the orthosis for periods of between six and 45 months was undertaken in order to establish the degree of benefit. 17 patients had no power in hips or below, the rest having some power in one or both hips. 17 patients had dorsal lesions and the remainder had lumbar lesions. Using Hoffer's (1973) classification, 13 patients had improved ambulation when using the hip guidance orthosis, and most of the remainder showed some measurable improvement in ambulation. 14 patients were tested for speed of ambulation and heart rate before and after use of the orthosis, and the mean increase in speed was 87.3 per cent, with a mean decrease in heart rate of 10bpm--a clear improvement in efficiency. The results indicate that the hip guidance orthosis can provide low-energy ambulation for spina bifida patients with dorsal and high lumbar lesions in a form acceptable both to patients and parents.
Postural Stability in Children with High Sacral Level Spina Bifida: Deviations from a Control Group. [2021]Objective: To assess static and dynamic postural stability changes in children with high sacral level spina bifida.Methods: Thirty-five children with high sacral level spina bifida and 35 age-matched healthy controls were enrolled. Their lower extremity muscle strengths and static and dynamic postural stability parameters were measured with the use of a dynamometer and the NeuroCom Balance Master® device, respectively. Functional gait and balance were evaluated using the five times sit-to-stand test (5STS) and the 6-minute walk test (6MWT). Spinal, hip, and ankle deformities of the patient group were measured by radiologic evaluation.Results: In comparison with controls, patients were found to have lower ankle dorsiflexion and plantar-flexion strength, increased 5STS duration, and decreased 6MWT distance while both static and dynamic postural stability parameters were significantly different. Bilateral ankle muscle strengths were found to be negatively correlated with postural stability parameters. The presence of hydrocephalus or meningomyelocele in the patient group was found to have negative effects on static postural stability.Conclusion: Static and dynamic postural stability is affected even in children with high sacral level spina bifida who are expected to have best condition in this patient population. The ankle muscle strength is the main factor influencing these changes.
[Current status of orthotic management of children with meningomyelocele]. [2006]The supplying of Spina bifida children with orthotic devices leads to a remarkable success only, if it is based on the preexisting possibilities of the overall development and the present situation of the child. To realize the aim of maximum autonomy in standing and walking this overall analytic perspective is a must for all therapeutic planing and decisions. Therefore, static and dynamic orthoses like hip guidance-combined with above-knee orthoses, standing and walking-aids like reciprocating gait orthoses etc. are decisive assumptions. The most important characteristics of all orthoses are, the child to feel the economizing effect concerning standing and walking. Then only optimum acceptance and integration of the orthotic devices into activities of daily living can be achieved.
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]Purpose: To determine the effects of sit-to-stand exercise programs on patient-related outcomes in people with physical impairments due to health conditions.Methods: This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered prospectively. Seven electronic databases were systematically searched for relevant articles. Inclusion and exclusion criteria were used to screen the titles and abstracts of articles identified using the key search terms of sit-to-stand and exercise. Only randomized controlled trials were included. The methodological quality of papers was assessed using the Cochrane risk of bias tool.Results: A total of eight trials were included. A meta-analysis was conducted using four of the trials that focused on patients with neurological conditions. There was moderate-quality evidence that sit-to-stand exercise programs improve sit-to-stand performance, but no evidence from another meta-analysis that sit-to-stand training improved balance for patients with neurological conditions. There was also no evidence from individual trials that positive changes occurred in the outcomes of gait speed and distance, lower limb muscle strength, falls, or participation.Conclusions: Sit-to-stand training could be a useful intervention when patients have limited sit-to-stand function and the aim of treatment is to improve this performance.IMPLICATIONS FOR REHABILITATIONSit-to-stand training could be a useful intervention for patients when the aim is to improve sit-to-stand performance.Sit-to-stand training may not be a useful intervention when the aim is to improve other functions such as balance.
Origin and treatment of fractures in spina bifida. [2022]Children with spina bifida cystica have a high risk of fracturing their paraplegic legs. During the last fifteen years we observed 261 fractures and epiphyseal injuries in 173 children out of 1,400 (12.2%) patients with spina bifida. The increased risk of fracture seems to be due to reduced muscle activity in the paralysed limb with insufficient axial loading of the legs. A large proportion of fractures occurs after orthopedic interventions. Fractures are less common after urologic or neurosurgical procedures. Breaks are extremely frequent after operations in association with cast immobilization. Early standing and short immobilization times are the best defence mechanisms against fractures. If plasters are needed postoperatively one should preferably use the "Max and Moritz" standing cast. Fractures in spina bifida children heal quickly as compared to those in non-paralyzed children. In 30% excessive callus is seen. Immobilization for fracture care can be done in a standing cast even in the very early phase of treatment. In spite of the swelling and elevated temperature axial loading in the standing cast should continue. Splints and braces can be used instead of the plaster cast. By any means, the vicious circle of Fracture-Plaster-Fracture-Plaster should be avoided. Repeated stress on the growth plate causes a mechanism of loosening. The most common site is the distal tibia and femur, less often loosenings occur in the proximal tibia and proximal femur. Epiphyseal loosening is a nosological entity seen in spina bifida and also in congenital absence of sensation. Distal tibial epiphyseal loosening is frequently seen in adolescents who have learned to walk only after muscle balancing procedures in the hips.(ABSTRACT TRUNCATED AT 250 WORDS)
Spina bifida and cerebral palsy. [2007]A new test of posture and mobility has been applied to a small group of spina bifida children with different lower limb motor levels, and to a further group of children with both spina bifida and associated cerebral palsy of the hemiplegic type. It is demonstrated that this test of posture and mobility is applicable to spina bifida children and that gross motor handicap is therefore quantifiable. The posture and mobility scores of children with spina bifida or cerebral palsy is significantly less than those of normal children and the scores for children with both spina bifida as well as cerebral palsy is significantly lower than having either alone.
The development of equipment by the RCA. [2019]This paper describes the continuation of the work of the Royal College of Art team outlined in the preceding paper, and illustrates the development of some standard items of equipment to suit children with spina bifida. The standard items consist of a combined w.c. and shower seat and a height adjustable dressing/treatment bench. A situation in which items have been used is described and future developments are outlined.