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Clinical Trials/NCT06628934
NCT06628934
Active, Not Recruiting
N/A

Wearable Sensors for Quantitation of Impaired Gait and Balance

University of Chicago1 site in 1 country600 target enrollmentJune 23, 2017

Overview

Phase
N/A
Intervention
Spinocerebellar Ataxia
Conditions
Spinocerebellar Ataxia
Sponsor
University of Chicago
Enrollment
600
Locations
1
Primary Endpoint
iSARA
Status
Active, Not Recruiting
Last Updated
2 months ago

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 Spinocerebellar ataxia.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2017
End Date
December 31, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Spinocerebellar Ataxia

Individuals with genetically-confirmed diagnosis of SCA

Healthy Controls

Healthy Controls

Outcomes

Primary Outcomes

iSARA

Time Frame: 8 Years

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

Secondary Outcomes

  • Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)(8 Years)
  • Activities-specific Balance Confidence (ABC) Scale(8 Years)
  • EQ-5D-5L(8 Years)

Study Sites (1)

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