To evaluate the effect of the balance assisting device *GyBAR* on balance capacity during standing and gait tasks in people with pure degenerative ataxia.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The participant*s experience with the GyBAR as a balance assisting device will
be assessed via a 5-point Likert Scale.
Background summary
People with degenerative ataxia experience disabling balance and gait
impairments. These arise due to the progressive coordination difficulties of
both the extremities and trunk. As a result, falls and fear of falling are
common among people with degenerative ataxia. Recently, the backpack GyBAR has
been developed to provide overground balance assistance. In the current study,
we will conduct exploratory measurements to evaluate the potential efficacy of
the GyBAR in potential end users; individuals with degenerative ataxia.
Study objective
To evaluate the effect of the balance assisting device *GyBAR* on balance
capacity during standing and gait tasks in people with pure degenerative
ataxia.
Study design
An explorative observational cross-sectional study.
Intervention
Wearing of the GyBAR backpacl
Study burden and risks
The risks associated with participation will be negligible. Participants will
wear a safety harness during the assessment which prevents them from falling.
Burden association with the assessments will be limited, as participants will
have one assessment with an expected duration of two hours.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
- Other neurological or orthopaedic conditions impacting on balance and/or gait
performance.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82737.091.22 |