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

Friedreich's Ataxia Clinical Trial

— STAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179333
• Other study ID #: STAND2012
• Status: Completed
• Start date: October 2012
• Est. completion date: June 2016

Study information

• Verified date: November 2021
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Friedreich Ataxia
• Friedreich's Ataxia
• Neurologic Manifestations
• Spinocerebellar Ataxia - All Sub-types
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

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

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter- and intra-rater agreement	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).	4 to 6 weeks

External Links

•   USF Ataxia Research Center