Longitudinal Gait and Balance Measurement

  • STATUS
    Recruiting
  • sponsor
    Friedreich’s Ataxia Research Alliance
Updated on 23 November 2020

Summary

Longitudinal Gait and Balance Measurement

Description

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.

Protocol Number: Gait and Balance study

Details
Clinical Study IdentifierTX141156
SponsorFriedreich’s Ataxia Research Alliance
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

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
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