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

NCT02179333 | Completed

• 1 other identifier: STAND2012
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinocerebellar Ataxia - All Sub-types; Friedreich's Ataxia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Subjects with Ataxia

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.

Other: Ataxia rating scale

Interventions

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.

Subjects with Ataxia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community members, support group members or clinic patients with ataxia.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Friedreich Ataxia

Condition Hierarchy (Ancestors)

Spinocerebellar Degenerations; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)