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

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ClinicalTrials.gov Identifier: NCT02179333
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida

Study Description
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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.

Condition or disease Intervention/treatment
Spinocerebellar Ataxia - All Sub-types Friedreich's Ataxia Other: Ataxia rating scale

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Study Start Date : October 2012
Actual Primary Completion Date : June 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179333


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

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Responsible Party: Theresa Zesiewicz, Professor of Neurology, University of South Florida
ClinicalTrials.gov Identifier: NCT02179333    
Other Study ID Numbers: STAND2012
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Friedreich Ataxia
Neurologic Manifestations
Dyskinesias
Nervous System Diseases
Cerebellar Diseases
 Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases