APDM Instrumented Data Exchange for Ataxia (IDEA) Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinocerebellar Ataxia Type 1
- Sponsor
- University of Chicago
- Enrollment
- 128
- Locations
- 5
- Primary Endpoint
- iSARA
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •dementia that limits subjects' ability to follow directions
- •pain that limits mobility
- •SCA: enrolled in a clinical drug trial
Outcomes
Primary Outcomes
iSARA
Time Frame: 2 years
measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
Ataxia App on Watch/iPhone
Time Frame: 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
Time Frame: 2 years
Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
Functional Staging
Time Frame: 2 years
Clinician evaluates severity of ataxia symptoms.
mFARS
Time Frame: 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)
Time Frame: 2 weeks
APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
SARA
Time Frame: 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
Time Frame: 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
Time Frame: 2 years
Subjects walk for 25 feet, as quickly and safely as possible, while being timed