Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
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.
|Spinocerebellar Ataxia - All Sub-types
|Other: Ataxia rating scale|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)|
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).
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|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.
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.
|Ages Eligible for Study:||18 Years to 80 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Community members, support group members or clinic patients with ataxia.
- 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.
- Any illness that in the investigator's opinion preclude participation in this study.
- Subjects with a cardiac pacemaker
- Legal incapacity or limited legal capacity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02179333
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
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:
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
ClinicalTrials.gov processed this record on July 01, 2014