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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Muscular Atrophy
• Intervention / Treatment: Other: ACTIVE mini

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

SMA

Description

Inclusion Criteria:

-

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.

These inclusion criteria are set for both affected babies and healthy controls.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal Muscular Atrophy Type 1; Non rolling infants or children with SMA	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.
Non Rolling Function matched control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Motor Neuron Disease; Muscular Atrophy; Atrophy; Muscular Atrophy, Spinal
• Other Study ID Numbers: STU 052016-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No