An observational study in Spinal Muscular Atrophy, sponsored by University of Texas Southwestern Medical Center. Completed. Per ClinicalTrials.gov, last updated 2019-01-17.
Sponsored by University of Texas Southwestern Medical Center · Observational
The purpose of this study is to investigate the measurement properties of the Ability Captured Through Interactive Video Evaluation-mini (ACTIVE-mini) for quantifying movement in infants with Spinal Muscular Atrophy (SMA). Specifically, I will investigate within-day and between-day test-retest reliability and calculate the minimal detectable change of the ACTIVE-mini. Additionally, I will determine the concurrent validity of the ACTIVE-mini with The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND) and the construct validity of the ACTIVE-mini in infants with SMA using a known group methodology.
This study was a cross-sectional, repeated measure design, investigating the test-retest within- and between-day reliability and the convergent construct validity and the known-groups method construct validity of the ACTIVE-mini. The group variable included two levels (non-rolling infants with SMA and function matched non-rolling typically developing infants). The dependent variables included a predicted CHOP INTEND score determined by data captured by the ACTIVE-mini and the CHOP INTEND extremity score. The dependent variables were collected at two time points over two days at a minimum of 24 hours and no more than 30 days between collections. Variables were collected in a standard order of assessment. All participants underwent all assessments as set out in the procedures. Based on results from pilot data, the conclusion was made that the ACTIVE-mini could quantify infant movement parameters well enough to warrant further investigation. These data were important in establishing the feasibility of the specific aims of this research, because they provide initial validation of the ability of ACTIVE-mini to quantify basic infant movement parameters
494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.
This study's enrollment of 25 is below the median of 72 across 139 observational studies indexed under Muscular Atrophy.
Browse Muscular Atrophy studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
SMA
-
Participants will be included in this study if they:
These inclusion criteria are set for both affected babies and healthy controls.
Exclusion Criteria:
Participants will be excluded from this study if they:
Non rolling infants or children with SMA
Other: ACTIVE mini
Non rolling typically developing infant
Other: ACTIVE mini
the ACTIVE-mini, is a non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.
ACTIVE mini
the ACTIVE-mini, is a physiological parameter non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.
Time frame: 2 minutes
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center