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

University of South Florida1 site in 1 country30 target enrollmentOctober 2012

ConditionsSpinocerebellar Ataxia - All Sub-types Friedreich's Ataxia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinocerebellar Ataxia - All Sub-types
Sponsor: University of South Florida
Enrollment: 30
Locations: 1
Primary Endpoint: Inter- and intra-rater agreement
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

June 2016

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of South Florida

Responsible Party

Principal Investigator

Theresa Zesiewicz, MD

Professor of Neurology

University of South Florida

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).