Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 27, 2014
First Posted Date July 1, 2014
Last Update Posted Date June 29, 2016
Study Start Date October 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2014)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Official Title Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community members, support group members or clinic patients with ataxia.
Condition
  • Spinocerebellar Ataxia - All Sub-types
  • Friedreich's Ataxia
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Ataxia rating scale
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2014)
30
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02179333
Other Study ID Numbers STAND2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Theresa Zesiewicz, University of South Florida
Study Sponsor University of South Florida
Collaborators Not Provided
Investigators Not Provided
PRS Account University of South Florida
Verification Date June 2016