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The functional evaluation of a wearable gyroscopic actuator (GyBAR) to support balance in people with degenerative ataxia

The functional evaluation of a wearable gyroscopic actuator (GyBAR) to support balance in people with degenerative ataxia - GyBAR Ataxia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51752
Enrollment
15
Registered
2023-01-26
Start date
2023-03-23
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

coordination disorder movement disorder

Interventions

Wearing of the GyBAR backpacl

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of pure degenerative ataxia based on molecular diagnosis or clinical assessment by a neurologist specialized in movement disorders - Age between 18-70 years old - Difficulties with gait where the participant cannot perform tandem walking (heels to toes) over ten steps and staggering occurs while performing a half turn (though it is possible to complete the turn without support (Score of 2 or 3 on item 1 *Gait* of the Scale for the assessment and rating of ataxia (SARA)) - Difficulties while standing that arise when the participant is asked to stand with feet together, whereas standing in natural position is possible for over 10 seconds; (Score of 3 on item 2 *Stance* of the SARA scale) - Being able to wear a backpack of 6 kilograms for a duration of two hours

Exclusion criteria

Exclusion criteria: - Other neurological or orthopaedic conditions impacting on balance and/or gait performance.

Design outcomes

Primary

MeasureTime frame
Participants will perform 6 tasks. We have defined a main study parameter per task Task 1: Quiet stance for 30 seconds Main study parameter: the root mean square of center of pressure velocity Task 2: Walking at self-selected comfortable speed for 3 minutes on the treadmill Main study parameter: root mean square of mediolateral center of mass position Task 3: 360° turn-in-place Main study parameter: jerkiness of the performed turn Task 4: Quiet standing in tandem stance (heel touches toe) for as long as possible Main study parameter: maximum duration (seconds) of standing in tandem stance. Task 5: Walking in tandem gait for as many steps as possible Main study parameters: maximum number of correct steps taken by the participant Task 6: Balance recovery from treadmill-induced sideways balance perturbations. Main study parameter: success of a feet-in-place recovery (i.e. the participant are able to recover their balance without taking a step). Secondary study parameter: margin of stability, defined as the distance between the body*s extrapolated center of mass (a measure that incorporates both center of mass position and velocity) and the edge of the base of support.

Secondary

MeasureTime frame
The participant*s experience with the GyBAR as a balance assisting device will be assessed via a 5-point Likert Scale.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)