Reliability and Validity of the ACTIVE-mini for Quantifying Movement in Infants With Spinal Muscular Atrophy

NCT03808233 | Completed

• 1 other identifier: STU 052016-109
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 minutes

Study Arms (2)

Spinal Muscular Atrophy Type 1

Non rolling infants or children with SMA

Other: ACTIVE mini

Non Rolling Function matched control

Non rolling typically developing infant

Other: ACTIVE mini

Interventions

ACTIVE mini OTHER

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.

Non Rolling Function matched control; Spinal Muscular Atrophy Type 1

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SMA

You may qualify if:

• Participants will be included in this study if they:
• are non-rolling at time of enrollment
• age birth to 25 months
• have no concomitant system pathology that would limit clinical evaluation.

You may not qualify if:

• Participants will be excluded from this study if they:
• demonstrate evidence of renal dysfunction, central nervous system damage, neuro-degenerative or neuromuscular disease other than SMA type I or II;
• require mechanical ventilation of any type \> 16 hours per day.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: January 17, 2019
• Study Start: November 5, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 31, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share