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

NCT ID: NCT02179333

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Spinocerebellar Ataxia - All Sub-types Friedreich's Ataxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ataxia rating scale

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Theresa Zesiewicz, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Related Links

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http://health.usf.edu/medicine/neurology/ataxia/index.htm

USF Ataxia Research Center

Other Identifiers

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STAND2012

Identifier Type: -

Identifier Source: org_study_id