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Completed

NCT Number: NCT02179333

Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

The objectives of this study are:

* To validate the inter-rater and intra-rater reliability of a new scale for the assessment of ataxia and neurologic dysfunction (STAND) * To assess common constructs and correlation between STAND subscale items.

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Key information

Conditions

Spinocerebellar Ataxia - All Sub-types Brain Diseases Central Nervous System Diseases Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Friedreich Ataxia Friedreich's Ataxia Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Spinocerebellar Degenerations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida

Tampa, Florida, 33612, United States

About this study

There are few validated, comprehensive rating scales for the assessment of ataxia severity. The development of a Scale To assess Ataxia and Neurologic Dysfunction (STAND) would examine and measure as many facets of ataxia as possible. Scale items to be measured include parkinsonism, timed gait analysis, dystonia, neuropathy and peripheral nerve weakness, as well as other areas of clinical manifestation for ataxia. This brief but thorough scale should yield a thorough measurement of ataxia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ataxia.
  • Male or female between 18 and 80 years of age.
  • Subject has voluntarily signed an IRB approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.

Exclusion criteria

  • Any illness that in the investigator's opinion preclude participation in this study.
  • Subjects with a cardiac pacemaker
  • Legal incapacity or limited legal capacity.

Treatment and study plan

Ataxia rating scale

Other

Administer new rating scale for ataxia. This will be administered by two different raters on two separate occassions, 4 to 6 weeks apart.

Primary outcomes

  1. Inter- and intra-rater agreement

    Time frame: 4 to 6 weeks

    Assess agreement between raters (inter-rater agreement) and within raters (intra-rater agreement) through the evaluation of STAND total score, subtotals and individual variables using intraclass correlation coefficients (ICCs).

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Acronym: STAND

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2014
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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