Instrumented Data Exchange for Ataxia Study

University of Chicago128 enrolled

Overview

This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Friedreich Ataxia

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing * SCA: aged 18-75 years * FA: aged 12-30, diagnosed between ages 5-25 * community dwelling * physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement * able to walk independently 10 yards without an assistive device * able to sit or stand unassisted for 30 seconds * no other neurological or musculoskeletal disorder that could affect mobility * no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility * willing and able to participate in a 2-year study * consent to be video recorded while performing study assessments Exclusion Criteria: * dementia that limits subjects' ability to follow directions * pain that limits mobility * SCA: enrolled in a clinical drug trial

Locations (5)

University of California-Los Angeles

Los Angeles, California, United States

The University of Chicago

Chicago, Illinois, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Mass General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

iSARA

measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)

Time frame: 2 years

SARA

Scale for the Assessment and Rating of Ataxia (SARA) measurements evaluated by clinician to measure severity of spinocerebellar ataxia through coordination, speech, stance, and gait

Time frame: 2 years

mFARS

modified Friedreich's Ataxia Rating Scale (mFARS) measurements evaluated by clinician compared to measure severity of Friedreich's ataxia through coordination, speech, stance, and gait

Time frame: 2 years

Daily Life (UChicago site ONLY)

APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects

Time frame: 2 weeks

Ataxia App on Watch/iPhone

Bi-weekly assessments completed on Ataxia Application for Apple Watches and iPhones. Data collected includes active monitoring of speech, stance, coordination, gait and patient-reported symptoms.

Time frame: 2 years

Patient-Reported Questionnaires of Health

Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)

Time frame: 2 years

Falls Questionnaire

Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month

Time frame: 2 years

Data from ClinicalTrials.gov

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