Friedreich ataxia: balance and gait study

A longitudinal laboratory and real-world study of gait and balance in people with Friedreich ataxia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN40092306

Enrollment

Registered

2023-11-02

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Friedreich ataxia Nervous System Diseases

Interventions

This study is a collaboration between the Wellcome Centre for Mitochondrial Research, Newcastle, UK, and the Hertie Institute for Clinical Brain Research and Centre for Integrative Neuroscience, Tubin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Genetically confirmed Friedreich’s Ataxia 2. Aged 14 to 65 years 3. Able to stand and walk unaided for at least 20 m 4. Able to provide informed consent 5. Able to follow instructions and comply with the study protocol 6. Willing to wear a small sensor on the lower back for seven consecutive days 7. No other known neurological or musculoskeletal disorder affecting balance and mobility

Exclusion criteria

Exclusion criteria: 1. Lacking the capacity to provide informed consent 2. Enrolled in interfering therapy or clinical drug trial currently or within last 3 months 3. Pregnancy at the time of enrolment 4. Any other reason, which in the opinion of the recruiting investigator would preclude involvement in the study

Design outcomes

Primary

Measure	Time frame
Balance and gait measured using stabilometry (force plate analysis), an instrumented walkway (GaitRite) and wearable sensors (Ax6 and Opal) at baseline, month 6 and month 12	—

Secondary

Measure	Time frame
1. Investigate how balance and gait outcomes are influenced by wearable sensor location and configuration (i.e. single sensor vs. 3 Opal sensors) measured using gait data generated in a specialist gait laboratory and in the real world at baseline, month 6 and month 12 2. Validate gait outcomes measured using the wearable sensors against gait outcomes measured via the instrumented walkway at baseline, month 6 and month 12 3. Compare data collected in the real world via wearable sensor with data from clinical rating scales, questionnaires and gait laboratory assessments at baseline, month 6 and month 12	—

Measure

Time frame

1. Investigate how balance and gait outcomes are influenced by wearable sensor location and configuration (i.e. single sensor vs. 3 Opal sensors) measured using gait data generated in a specialist gait laboratory and in the real world at baseline, month 6 and month 12 2. Validate gait outcomes measured using the wearable sensors against gait outcomes measured via the instrumented walkway at baseline, month 6 and month 12 3. Compare data collected in the real world via wearable sensor with data from clinical rating scales, questionnaires and gait laboratory assessments at baseline, month 6 and month 12

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026