Instrumented Data Exchange for Ataxia Study

Completed

• Conditions: Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 1; Friedreich Ataxia; Spinocerebellar Ataxia Type 3; Spinocerebellar Ataxia Type 6

• Registration Number: NCT04268147
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iSARA	2 years	measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
Ataxia App on Watch/iPhone	2 years	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.
Falls Questionnaire	2 years	Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
Functional Staging	2 years	Clinician evaluates severity of ataxia symptoms.
mFARS	2 years	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
Daily Life (UChicago site ONLY)	2 weeks	APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
SARA	2 years	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
Patient-Reported Questionnaires of Health	2 years	Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)
Timed 25 Foot Walk	2 years	Subjects walk for 25 feet, as quickly and safely as possible, while being timed

Trial Locations

Locations (5)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of California-Los Angeles; 🇺🇸 Los Angeles, California, United States