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

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

This study is ongoing, but not recruiting participants.
Sponsor:
University of South Florida
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT02179333
First received: June 27, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
Purpose

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.

Condition Intervention
Spinocerebellar Ataxia - All Sub-types
Friedreich's Ataxia
Other: Ataxia rating scale

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Inter- and intra-rater agreement [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
    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).

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Administer new rating scale for ataxia. This will be administered by two different raters on two separate occassions, 4 to 6 weeks apart.

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.

Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

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

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.

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179333

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
More Information

Additional Information:
No publications provided

Responsible Party: Theresa Zesiewicz, Professor of Neurology, University of South Florida
ClinicalTrials.gov Identifier: NCT02179333 History of Changes
Other Study ID Numbers: STAND2012
Study First Received: June 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Friedreich Ataxia
Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Neurologic Manifestations
Dyskinesias
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Cerebellar Ataxia

ClinicalTrials.gov processed this record on July 01, 2014