AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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 groups in NCT02341053
Study groupRoleWhat they receive
Load-measuring platformOtherLoad-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.

  1. 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)
  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.

  1. First posted19 Jan 2015 (estimated)
  2. Study start8 Sep 2016
  3. Primary completion25 Jul 2018
  4. Study completion25 Jul 2018

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in