Clinical Trial Details

Overview

Research Study Summary

Longitudinal Gait and Balance Measurement

Purpose

A prospective longitudinal study, measuring gait and balance of ambulatory people with FRDA over a 12 month period of time, will be conducted. Gait and balance measures will be assessed at baseline, 6 months and 12 months.

To Learn more

CW ID: 209939
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
7 and up
Overall Status
Recruiting
Lead Sponsor
Friedreich’s Ataxia Research Alliance
Duration
12 Months
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Diagnosis of FRDA, genetically documented to be due to homozygosity for a GAA repeat expansion in intron 1 of FXN
  • Aged 7 and above
  • Able to complete all the outcome measures safely as determined by the multidisciplinary team at the USF Ataxia Research Center and Human Functional Performance Laboratory
  • Able to ambulate independently without a gait aid during the baseline assessment*

Exclusion Criteria:

  • Compound heterozygotes for a GAA expansion in intron 1 and a point mutation in the FXN gene
  • Any injury or other medical condition limiting ability to weight-bear or ambulate that is not related to FRDA in the judgement of the investigator
  • Unable to walk independently without a gait aid*
  • Aged under 7 years
  • Unable to complete all the outcome measures safely
  • Enrolled in a clinical trial during the baseline assessment and six month assessment
  • Anticipated to require a change in exercise regimen or require a non-standard or new therapeutic intervention for reduced mobility between the baseline and six month assessment as assessed by the multidisciplinary team at the USF Ataxia Research Center. This includes an inpatient admission or botulinum toxin injection

*Recruitment will be monitored and if there are difficulties with recruitment, the ability to ambulate with a gait aid will be added to the eligibility criteria and exclusion criteria will be adjusted to allow inclusion of participants who are able to independently ambulate with a gait aid.

More Info

Protocol Number: Gait and Balance study

Contact

Tanya Aranca
University of South Florida- Morsani Center for Advanced Healthcare- Ataxia Research Center and Human Functional Performance Laboratory
13330 USF Laurel Drive
Tampa, FL 33612
Phone: 813-974-5335

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