Wearable Gait Sensors

Wearable Sensors for Quantitation of Impaired Gait and Balance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06628934

Enrollment

600

Registered

2024-10-08

Start date

2017-06-23

Completion date

2026-12-31

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
iSARA	8 Years	Digital measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA).

Secondary

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

Countries

United States

Outcome results