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
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Purpose
Detailed Description:
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:
Genetics Home Reference related topics: ataxia neuropathy spectrum autosomal recessive cerebellar ataxia type 1 childhood myocerebrohepatopathy spectrumdeoxyguanosine kinase deficiency Friedreich ataxia infantile-onset spinocerebellar ataxia Marinesco-Sjögren syndrome mitochondrial neurogastrointestinal encephalopathy diseasemyoclonic epilepsy myopathy sensory ataxia spinocerebellar ataxia type 1 spinocerebellar ataxia type 2 spinocerebellar ataxia type 3 spinocerebellar ataxia type 6 VLDLR-associated cerebellar hypoplasia
MedlinePlus related topics: Friedreich's Ataxia
U.S. FDA Resources Further study details as provided by University of South Florida:
Primary Outcome Measures:
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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
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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2014
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