Gait and Bone Health in SMA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-50
SponsorJacqueline Montes
About this trial
The objective of this study is to understand how spatiotemporal and kinetic gait parameters are associated with bone health in pwSMA who are receiving DMT. We hypothesize that gait parameters are associated with BMD and can determine fracture risk in pwSMA. This is an observational study that involves one in-clinic visit (approximately 3 hours) with remote follow-up visits (approximately 15 minutes) every 3 months for 1 year to collect fracture and medical history. Each of the assessments included in this study are non-interventional and are not intended as a treatment nor are they at the level of standard of care.
Eligibility criteria
Qualifiers
Confirmed diagnosis of 5qSMA
Between 8 and 50 years of age
Able to walk 10 meters without support or an assistive device
All participants who meet the inclusion criteria regardless of treatment status will be included, including those on adjuvant therapies, whether investigational or approved
Disqualifiers
Injury or surgery within previous 3 months that would impact ability to perform in-clinic gait assessments
Unwilling or unable to comply with all study procedures
Age less than 8 or over 50 years
Trial design
Treatments tested in this trial
- Not listed
Trial groups
22 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov