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Trial record 29 of 124 for:    "Progressive Muscular Atrophy"

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

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ClinicalTrials.gov Identifier: NCT03808233
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment
Spinal Muscular Atrophy 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

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability and Validity of the ACTIVE-mini for Quantifying Movement in Infants With Spinal Muscular Atrophy
Actual Study Start Date : November 5, 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : August 31, 2018


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.




Primary Outcome Measures :
  1. ACTIVE mini [ Time Frame: 2 minutes ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
SMA
Criteria

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.

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03808233     History of Changes
Other Study ID Numbers: STU 052016-109
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Atrophy
Muscular Atrophy, Spinal
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases