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ID
Source
Brief title
Health condition
Parkinson's disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence and percent time of FOG (total FOG duration divided by the total walking duration). The presence and percent time of FOG will be determined via offline visual analysis of the videos by experienced raters.
Secondary outcome
Spatiotemporal gait parameters as obtained by instrumented gait analysis (Xsense), including velocity, step length, cadence and relative durations of the single and double limb support phases). In addition, patients’ experience will be evaluated using standardized questionnaires.
Background summary
Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson’s disease (PD). Non-pharmacological approaches, including external cueing, are generating growing interest. However, it remains difficult to translate such cueing strategies into an efficient ambulatory device that is effective, but at the same time socially acceptable (i.e. ‘invisible’ to outsiders). In this regard, tactile cueing holds great promise. Here, we propose rhythmically vibrating socks as a new ambulatory device to improve gait and alleviate FOG in PD. The vibrating socks can offer tactile cueing in an open-loop (fixed frequency) or closed-loop manner (vibration is activated when 80% of body weight is placed on the sock. We expect both types of tactile cueing to be feasible and effective, with tactile cueing being preferential over auditory cueing.
Using a within-subject design, we will test the ability of vibrating socks, a new tactile cueing device for the management of FOG in patients with PD. We will include 40 PD patients with a recent history of disabling/regular FOG in two medical centres (Medisch Spectrum Twente and Radboud UMC).
Measurements will be conducted during two separate mornings (max. 4 hours per session), one while ON dopaminergic medication and one while OFF dopaminergic medication (>12 hours after intake of the last dose of medication). During both sessions motor (MDS-UPDRS part III) and cognitive status (FAB and MMSE) will be tested. Additionally, patients will perform four different walking tasks ((1) walking at preferred speed for 10 m, (2) turning while walking, (3) gait trajectory with narrow passages, (4) rapid full turns) in four different conditions ((1) tactile cueing in a closed-loop manner; (2) tactile cueing in an open-loop manner; (3) auditory cueing; or (4) no cueing). Each walking test will be performed three times, and recorded on video.
Primary outcome measure will be the presence and percent time of FOG (total FOG duration divided by the total walking duration). The presence and percent time of FOG will be determined via offline visual analysis of the videos by experienced raters.
Secondary outcome parameters are the spatiotemporal gait parameters as obtained by instrumented gait analysis (Xsense), including velocity, step length, cadence and relative durations of the single and double limb support phases). In addition, patients’ experience will be evaluated using standardized questionnaires.
All outcome parameters will be compared between the four conditions (tactile closed loop cuing, tactile open loop cueing, auditory cueing and no cueing).
Study objective
We expect both types of tactile cueing (open- and closed loop) to be feasible and effective, with tactile cueing being preferential over auditory cueing.
Study design
24 months
Intervention
Vibrating socks, a new tactile cueing device
Marleen C. Tjepkema-Cloostermans
+31 53 487 2850
m.tjepkema-cloostermans@mst.nl
Marleen C. Tjepkema-Cloostermans
+31 53 487 2850
m.tjepkema-cloostermans@mst.nl
Inclusion criteria
Idiopathic Parkinson’s disease.
Recent history of disabling/regular freezing of gait (defined as presence of FOG several times a day in the past month and lasting longer than 1 second and verified objectively by an experienced neurologist).
Exclusion criteria
Gait impairments as a result of any other factor than Parkinson’s disease.
Sensory impairments (e.g. due to polyneuropathy) hampering patients to perceive vibration of the socks.
Cognitive impairments that causes the patient to be unable to understand the research purpose and accompanying instructions.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7679 |
CCMO | NL68729.044.19 |
OMON | NL-OMON48143 |