In PD patients: To investigate the effect of Levodopa on postural responses after translational perturbations. These outcomes will be helpful to decide whether patients in the cohort study should be measured in the ON or OFF medication state. In…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The stepping threshold, defined as the highest perturbation intensity (in m/s2)
at which balance is maintained with a feet in place response.
Secondary outcome
- Kinematic variables such as joint angles and Centre of Mass (CoM)
- Margin of Stability defined as the minimum distance between the vertical
projection of the CoM and the border of the Base of Support (BoS) during
perturbations at the stepping threshold.
- EMG (electromyographic) variables such as onset latency and amplitude.
Background summary
Falls are a major health problem in our aging population. Since balance
deficits are the most important risk factor for falls, it is not surprising
that in the population of Parkinson (PD) and stroke patients, in whom balance
deficits are very common, the problem of falls is paramount. We have planned a
prospective cohort study using a new experimental setup (Radboud Falls
Simulator) where we intend to predict falls and to better understand the
mechanisms of postural instability in PD and stroke patients. For both groups,
some questions remain to be answered to improve the interpretation of the
results of cohort study. These separate questions will be addressed in two
pilot studies as described in the current proposal.
Study objective
In PD patients: To investigate the effect of Levodopa on postural responses
after translational perturbations. These outcomes will be helpful to decide
whether patients in the cohort study should be measured in the ON or OFF
medication state. In addition, the results will provide more information about
the role of the dopaminergic system in postural stability in PD patients.
In stroke patients: To determine the effect of Weight Bearing Asymmetry (WBA)
on postural stability. Since WBA is common in stroke patients, the outcomes are
useful for the interpretation of the results of the cohort study. Furthermore,
the reusults give more insight in the mechanisms of balance control in stroke
patients.
Study design
Experimental study with repeated measurements.
Study burden and risks
Patients will have to visit the hospital for a balance assessment (1 visit for
stroke AND 2 visits for PD). During the balance assessment participants will be
exposed to balance perturbations by sudden translations of the support surface.
The risks of participating in the balance assessment are very small, since
rails are mounted around the balance platform and participants wear a safety
harness. PD patients will be measured in their medication OFF state once, which
means that they have to skip one dose of dopaminergic medication. This
procedure is completely safe and internationally accepted. After the
assessments, that will be planned in the morning, patients can take the missed
medication dose and continue the regular medication schedule.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
All participants:
- Functional Ambulation Categories 3-5
- Age 18 years and older
- Ability to stand independently (on bare feet) for at least 30 minutes
Stroke patients:
- Unilateral Supratentorial Stroke longer than 6 months ago
Parkinson patients:
- Idiopathic Parkinson's Disease
- Hoehn & Yahr Stages 1-3
Exclusion criteria
- Any other neurological or musculoskeletal disorder affecting balance
- Any inability to cooperate with the assessments and to give written informed consent
- Medication negatively affecting balance (e.g. neuroleptics, antidepressants, anticonvulsants, sedatives).
Design
Recruitment
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 | NL35969.091.11 |