PEARL-PD: Personalized gait rehabilitation in Parkinson's disease

Recruiting

Conditions: Gait impairment in Parkinson's disease
10028037

Registration Number: NL-OMON48450

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter of Study I is the correlation of patient characteristics to<br /><br>the effectiveness of each compensation strategy. The effectiveness of<br /><br>compensation strategies is expressed as percent change in gait variability<br /><br>while applying the strategy, compared to baseline gait variability. The main<br /><br>parameter of Study II is the difference in cortical activity, as measured by<br /><br>ambulatory EEG, during the application of selected compensation strategies<br /><br>compared to during baseline gait.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Study I<br /><br>- As a secondary outcome parameter we will look at spatiotemporal gait<br /><br>parameters, as collected by the Vicon motion analysis system<br /><br>- We will also assess the percentage of time spent frozen (as in: freezing of<br /><br>gait) during the gait task.<br /><br>- Finally we will include a Likert scale to assess the patient's level of<br /><br>confidence concerning the newly-acquired compensation strategy, and his/her<br /><br>intention to use the strategy in daily life.<br /><br><br /><br>Study II<br /><br>Spatiotemporal gait parameters, as collected by the Vicon motion analysis<br /><br>system</p><br>