Spinal Muscular DystrophyNCT02341053
Effects of Standing on Non-Ambulatory Children With Spinal Muscular Atrophy
A study testing Assisted Standing Treatment Program in people with Spinal Muscular Dystrophy and Neuromuscular Disability, run by Gillette Children's Specialty Healthcare at 1 site in United States.
Trial summary
Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Spinal Muscular Dystrophy, Neuromuscular Disability
- What is being tested?
- Assisted Standing Treatment Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2016to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-14 years old
- Diagnosed with Spinal Muscular Atrophy (SMA)
- Participating in a standing program using a stationary assisted standing device.
- Gross Motor Function Classification System (GMFCS) Level IV or V
- Parent must be able to provide consent.
Who cannot join
- 1. Currently on bisphosphonates
Trial locations and contacts
1 site in 1 country.
United States1 site
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at least in part, to abnormally low levels of load experienced by the skeleton. A common physical approach for increasing bone density is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this takes the form of using an assisted standing device to enable the child to spend time in a standing position with some degree of weight placed on the lower limbs. Some of these physical interventions demonstrate variable improvement in BMD in children with neuromuscular conditions, and some do not. A serious limitation in the previous work in this area is a failure to objectively measure the magnitude and duration of the loading experienced by the lower extremities. Thus, a lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight (due to load-sharing with the assistive device) for an inadequate duration of standing time.
In order to investigate the efficacy of standing treatment for increasing BMD, the investigators will develop a simple, portable and inexpensive transducer that will measure the magnitude and time course of the load experienced by the lower extremities of individuals with SMA who use a stationary assisted standing device. The specific goal of this proposed project will be to develop, validate and establish the initial feasibility of such a measurement device.
Read the detailed description
Background: Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at least in part, to abnormally low levels of load experienced by the skeleton. A common physical approach for increasing bone density is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this takes the form of using an assisted standing device to enable the child to spend time in a standing position with some degree of weight placed on the lower limbs. Some of these physical interventions demonstrate variable improvement in BMD in children with neuromuscular conditions, and some do not. A serious limitation in the previous work in this area is a failure to objectively measure the magnitude and duration of the loading experienced by the lower extremities. Thus, a lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight (due to load-sharing with the assistive device) for an inadequate duration of standing time.
Methods: In order to investigate the efficacy of standing treatment for increasing BMD, we will develop a simple, portable and inexpensive transducer that will measure the magnitude and time course of the load experienced by the lower extremities of individuals with SMA who use a stationary assisted standing device. This transducer will consist of an array of sensors embedded within a mat that will be placed under an individual's feet while they are in assisted standing. A prototype will be validated by comparing the output of this load-sensing mat against known loads that will be applied to the surface of the mat statically. The specific characteristics of the loading in the lower extremities of subjects can then be correlated with changes in their BMD to obtain a true outcome assessment. As a demonstration of this approach, we will recruit 3 children with SMA from Gillette Children's Specialty Healthcare who are currently participating in a standing program. Once enrolled and informed consent is obtained, the participants will use the mat provided to them to collect load and duration data during a baseline period where they will continue their standing program, and during a subsequent intervention period where they will increase the duration of their standing. The specific goal of this proposed project will be to develop, validate and establish the initial feasibility of such a measurement device.
Implications: Successful completion of this proposed project will provide the necessary groundwork to move forward with a multicenter clinical trial on a large number of subjects with a variety of neuromuscular conditions. The measurement device will allow us to correlate change in BMD with the specific load history for each participant, thereby allowing us to determine whether physical interventions can lead to increased BMD in individuals with neuromuscular disabilities. Analysis of the data will help define a dose-dependent relationship between load, duration and changes in BMD, thereby guiding providers and therapists in prescribing standing interventions.
- Being tested
- Assisted Standing Treatment Program
- Keywords
- SMA, Neuromuscular disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Standing Treatment ProgramOther
Assisted Standing Treatment Program - Assisted standing treatment program will be gradually increase duration of standing by up to 75% after baseline.
| Study group | Role | What they receive |
|---|---|---|
| Load-measuring platform | Other | Load-sensing platform A load-sensing platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device.
Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will gradually increase their duration of standing by up to 75% after the baseline phase. Receives: Other: Assisted Standing Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of load magnitude and duration data (Use load-sensing platforms to collect load magnitude and duration during standing treatment program)
Use load-sensing platforms to collect load magnitude and duration during standing treatment program.
Measured: 12 months
Secondary outcomes (1)
Bone Mineral Density
Determine whether an increase in the duration of standing leads to improvements in BMD, fracture incidence, pulmonary function and quality of life, and whether there is evidence that relationships exist between these outcome measures and load magnitude and duration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start8 Sep 2016
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gillette Children's Specialty Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Walter Truong, MD, Principal investigator, Gillette Children's Specialty Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341053
- Sponsor's protocol ID
- 1411M55281
- Status last verified
- Feb 2021
- First submitted
- 2 Jan 2015
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standing on Non-Ambulatory Children With Spinal Muscular Atrophy
- ClinicalTrials.gov ID
- NCT02341053
- Acronym / sponsor ID
- 1411M55281
- Keywords
- SMA, Neuromuscular disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Gillette Children's Specialty HealthcareUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at least in part, to abnormally low levels of load experienced by the skeleton. A common physical approach for increasing bone density is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this takes the form of using an assisted standing device to enable the child to spend time in a standing position with some degree of weight placed on the lower limbs. Some of these physical interventions demonstrate variable improvement in BMD in children with neuromuscular conditions, and some do not. A serious limitation in the previous work in this area is a failure to objectively measure the magnitude and duration of the loading experienced by the lower extremities. Thus, a lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight (due to load-sharing with the assistive device) for an inadequate duration of standing time.
In order to investigate the efficacy of standing treatment for increasing BMD, the investigators will develop a simple, portable and inexpensive transducer that will measure the magnitude and time course of the load experienced by the lower extremities of individuals with SMA who use a stationary assisted standing device. The specific goal of this proposed project will be to develop, validate and establish the initial feasibility of such a measurement device.
Detailed description
Background: Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at least in part, to abnormally low levels of load experienced by the skeleton. A common physical approach for increasing bone density is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this takes the form of using an assisted standing device to enable the child to spend time in a standing position with some degree of weight placed on the lower limbs. Some of these physical interventions demonstrate variable improvement in BMD in children with neuromuscular conditions, and some do not. A serious limitation in the previous work in this area is a failure to objectively measure the magnitude and duration of the loading experienced by the lower extremities. Thus, a lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight (due to load-sharing with the assistive device) for an inadequate duration of standing time.
Methods: In order to investigate the efficacy of standing treatment for increasing BMD, we will develop a simple, portable and inexpensive transducer that will measure the magnitude and time course of the load experienced by the lower extremities of individuals with SMA who use a stationary assisted standing device. This transducer will consist of an array of sensors embedded within a mat that will be placed under an individual's feet while they are in assisted standing. A prototype will be validated by comparing the output of this load-sensing mat against known loads that will be applied to the surface of the mat statically. The specific characteristics of the loading in the lower extremities of subjects can then be correlated with changes in their BMD to obtain a true outcome assessment. As a demonstration of this approach, we will recruit 3 children with SMA from Gillette Children's Specialty Healthcare who are currently participating in a standing program. Once enrolled and informed consent is obtained, the participants will use the mat provided to them to collect load and duration data during a baseline period where they will continue their standing program, and during a subsequent intervention period where they will increase the duration of their standing. The specific goal of this proposed project will be to develop, validate and establish the initial feasibility of such a measurement device.
Implications: Successful completion of this proposed project will provide the necessary groundwork to move forward with a multicenter clinical trial on a large number of subjects with a variety of neuromuscular conditions. The measurement device will allow us to correlate change in BMD with the specific load history for each participant, thereby allowing us to determine whether physical interventions can lead to increased BMD in individuals with neuromuscular disabilities. Analysis of the data will help define a dose-dependent relationship between load, duration and changes in BMD, thereby guiding providers and therapists in prescribing standing interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Load-measuring platform | Other | Other: Assisted Standing Treatment ProgramLoad-sensing platform A load-sensing platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device. Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will gradually increase their duration of standing by up to 75% after the baseline phase. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 3-14 years old
- Diagnosed with Spinal Muscular Atrophy (SMA)
- Participating in a standing program using a stationary assisted standing device.
- Gross Motor Function Classification System (GMFCS) Level IV or V
- Parent must be able to provide consent.
Key exclusion criteria (1 listed)
- 1. Currently on bisphosphonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted Standing Treatment ProgramAssisted Standing Treatment Program - Assisted standing treatment program will be gradually increase duration of standing by up to 75% after baseline. | Other | Load-measuring platform |
Primary outcome
Collection of load magnitude and duration data (Use load-sensing platforms to collect load magnitude and duration during standing treatment program)
Time frame: 12 months
Use load-sensing platforms to collect load magnitude and duration during standing treatment program.
1 secondary outcome
Bone Mineral Density
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Truong, MD principal investigator
Gillette Children's Specialty Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Standing Treatment Program in people with Spinal Muscular Dystrophy and Neuromuscular Disability, run by Gillette Children's Specialty Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of load magnitude and duration data (Use load-sensing platforms to collect load magnitude and duration during standing treatment program) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.