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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04268147
Other study ID # IRB18-1580
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 144
Est. completion date June 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 75 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States Johns Hopkins Medicine Baltimore Maryland
United States Mass General Hospital Boston Massachusetts
United States The University of Chicago Chicago Illinois
United States University of California-Los Angeles Los Angeles California
United States Oregon Health & Science University Portland Oregon

Sponsors (4)

Lead Sponsor Collaborator
University of Chicago APDM Wearable Technologies, Biogen, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary iSARA measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA) 2 years
Primary 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 2 years
Primary 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 2 years
Primary Daily Life (UChicago site ONLY) APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects 2 weeks
Primary 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. 2 years
Primary 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) 2 years
Primary Falls Questionnaire Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month 2 years
Primary Functional Staging Clinician evaluates severity of ataxia symptoms. 2 years
Primary Timed 25 Foot Walk Subjects walk for 25 feet, as quickly and safely as possible, while being timed 2 years
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