This project aims to provide a deeper understanding of compensation strategies for gait impairments in PD. Specifically, the key objectives are: (1) To correlate the effectiveness of each type of compensation strategy to individual patient…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter of Study I is the correlation of patient characteristics to
the effectiveness of each compensation strategy. The effectiveness of
compensation strategies is expressed as percent change in gait variability
while applying the strategy, compared to baseline gait variability. The main
parameter of Study II is the difference in cortical activity, as measured by
ambulatory EEG, during the application of selected compensation strategies
compared to during baseline gait.
Secondary outcome
Study I
- As a secondary outcome parameter we will look at spatiotemporal gait
parameters, as collected by the Vicon motion analysis system
- We will also assess the percentage of time spent frozen (as in: freezing of
gait) during the gait task.
- Finally we will include a Likert scale to assess the patient's level of
confidence concerning the newly-acquired compensation strategy, and his/her
intention to use the strategy in daily life.
Study II
Spatiotemporal gait parameters, as collected by the Vicon motion analysis
system
Background summary
Gait deficits are common and disabling in Parkinson*s disease (PD). Patients
use many different and typically self-developed strategies to compensate for
their gait impairments, such as rhythmically bouncing a ball while walking, or
counting while walking. However, specific compensation strategies can improve
gait in certain patients, but have no effect or even exacerbate gait
impairments in others. It is currently unknown which patient characteristics or
circumstances can predict the individual efficacy of the various compensation
strategies. Moreover, the underlying working mechanisms of these compensation
strategies are poorly understood. This lack of fundamental knowledge hampers
the development of much-needed personalized rehabilitation strategies,
resulting into a frustrating and time-consuming therapeutic struggle, which is
based on trial-and-error.
Study objective
This project aims to provide a deeper understanding of compensation strategies
for gait impairments in PD. Specifically, the key objectives are: (1) To
correlate the effectiveness of each type of compensation strategy to individual
patient characteristics (Study I); and (2) To unravel the mechanisms of action
of various compensation strategies, using ambulatory electro-encephalography
(EEG) (Study II). These insights will pave the way towards a more personalized
rehabilitation approach for gait impairment in PD. It will also provide us with
more information on the cortical areas involved in gait control.
Study design
This project entails two separate studies, one for each primary objective:
- Study I: Using a within-patients design, the relationship between patient
characteristics and the efficacy of compensation strategies will be evaluated.
- Study II: Using a within-patient design, the underlying mechanism of three
different compensation strategies will be assessed by using ambulatory EEG.
Study burden and risks
Benefit: We expect all patients to potentially benefit from the compensation
strategies that are taught in Study I, which may result in improved gait
control.
Burden: For both studies patients will be (partially) assessed OFF-dopaminergic
medication, which is expected to cause an increase in Parkinsonian symptoms,
and an increase in discomfort during the measurement day(s). However, this is a
customary procedure which does not entail any risks. Patients may continue
their dopaminergic medication directly after the measurements.
Risks: Patients with PD and gait impairments are generally exposed to an
increased risk of falls compared to age-matched controls. Based on previous
literature on compensation strategy or *cueing* training, we do not expect
participation in this study to aggravate the risk of falls. Additionally,
during Study II, patients will be wearing a safety harness on the treadmill.
Therefore we do not expect potential issues of concern within this project.
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Men and women of age > 18 years with idiopathic Parkinson*s disease;
- Presence of disabling gait impairment, which they wish to be improved;
- Written informed consent.
Exclusion criteria
- Presence of major stroke in history or a psychiatric disease not related to
PD;
- Presence of severe co-morbidity limiting ambulation (eg. orthopaedic
problems);
- Inability to walk unaided (with the exception of a customary cane);
- Inability to walk for >3 minutes consecutively;
- Severe visual impairments, hampering perception of visual cues;
- Severe auditory impairments, hampering perception of auditory cues;
- Severe cognitive impairments, hampering the ability to give personal informed
consent or to comply to the study protocol.
Additional exclusion criteria for Study II:
- Presence of deep brain stimulation;
- Presence of epilepsy.
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 | NL70656.091.19 |