Efficacy of the Cue-shoe on freezing of gait and activity level: A pilot study

Recruiting

Conditions: Parkinsonism
10028037

Registration Number: NL-OMON40903

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

• stroke in history or a psychiatric
disease
• Any visual impairment or physical inability to perform the assessment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The statistical design will focus on the comparison between the two periods of<br /><br>Phase 2 (with and without visual cueing) on activity level.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• During Phase 1, the immediate effect of the Cue-shoe on gait parameters and<br /><br>FoG will be investigated by comparing the trials with and without cueing.<br /><br>• Application of a previously validated algorithm to detect FoG episodes and<br /><br>comparison of the two periods of Phase 2 (with and without visual cueing) on<br /><br>these data will give an idea of the functional efficacy of the Cue-shoe on FoG<br /><br>in the home environment.<br /><br>• The presence of a learning effect will be investigated by comparing the<br /><br>activity level and FoG during Phase 3 with those same measures during Phase 2.<br /><br>• For each of the home-based measurement, evolution of the activity level over<br /><br>days will be examined with the help of the patients' diaries.<br /><br>• Subjective impression of the patients on the Cue-shoe will be compared<br /><br>between each time point.<br /><br>• The Frontal Assessment Battery score will be used as a covariate in all<br /><br>performed analyses.</p><br>