Wearable Gait Sensors

N/AActive Not RecruitingNCT06628934

University of Chicago600 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 Spinocerebellar ataxia.

Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Spinocerebellar Ataxia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions. * Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions. Exclusion Criteria: * Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

iSARA

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

Time frame: 8 Years

Secondary Outcomes

Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)

Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The PROM-Ataxia is a 70-item assessment of physical, mental health, and activities of daily living, each scored on a 0-4 Likert scale. Scores are totaled.

Time frame: 8 Years

Activities-specific Balance Confidence (ABC) Scale

Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The ABC scale is a 16 item scale with a rating scale from 0 (no confidence) to 100 (complete confidence) in avoiding a fall. The score is determined by taking the average of all items.

Time frame: 8 Years

EQ-5D-5L

Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The EQ-5D-5L is a 5 item descriptive system to describe current mobility, self-case, usual activities, pain/discomfort, and anxiety/depression.

Time frame: 8 Years

Data from ClinicalTrials.gov

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