Friedreich ataxia: balance and gait study
Not Applicable
- Conditions
- Friedreich ataxiaNervous System Diseases
- Registration Number
- ISRCTN40092306
- Lead Sponsor
- ewcastle University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>2. Validate gait outcomes measured using the wearable sensors against gait outcomes measured via the instrumented walkway at baseline, month 6 and month 12<br>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