Parkinsonism
Conditions
Interventions
Use of the Cue-shoe to improve freezing of gait.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Men/women of age > 18 years. • Written informed consent. • Presence of freezing of gait (defined as a score of 1 on question 1 "Have you experienced FoG in the past month" from the New Freezing of Gait Questionnaire) • Disabling freezing of gait (defined as a score of 3 "Very often, more than one time a day" on question 2 "How often do you experience FoG" from the New Freezing of Gait Questionnaire)
Exclusion criteria
Exclusion criteria: • stroke in history or a psychiatric disease • Any visual impairment or physical inability to perform the assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The statistical design will focus on the comparison between the two periods of Phase 2 (with and without visual cueing) on activity level. | — |
Secondary
| Measure | Time frame |
|---|---|
| • During Phase 1, the immediate effect of the Cue-shoe on gait parameters and FoG will be investigated by comparing the trials with and without cueing. • Application of a previously validated algorithm to detect FoG episodes and comparison of the two periods of Phase 2 (with and without visual cueing) on these data will give an idea of the functional efficacy of the Cue-shoe on FoG in the home environment. • The presence of a learning effect will be investigated by comparing the activity level and FoG during Phase 3 with those same measures during Phase 2. • For each of the home-based measurement, evolution of the activity level over days will be examined with the help of the patients' diaries. • Subjective impression of the patients on the Cue-shoe will be compared between each time point. • The Frontal Assessment Battery score will be used as a covariate in all performed analyses. | — |
Countries
Netherlands
Outcome results
None listed