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

Completed

• Conditions: Friedreich's Ataxia; Spinocerebellar Ataxia - All Sub-types
• Interventions: Other: Ataxia rating scale

• Registration Number: NCT02179333
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Ataxia	Ataxia rating scale	Patients with a diagnosis of ataxia (Friedreich's ataxia or Spinocerebellar ataxia type 1-30) aged 18-80 years old will be recruited for the study.

Primary Outcome Measures

Name	Time	Method
Inter- and intra-rater agreement	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).

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States