NCT Number: NCT06894030
The goal of this clinical trial is to learn if cognitive cueing (eg., prompting individuals to think about taking big-long steps while walking), either as a stand- alone intervention or combined with a personalized gait training video, can improve gait (walking), mobility, and balance confidence for individuals with Parkinson's Disease. The main questions it aims to answer are:
1. Does focusing on cognitive cues while walking improve gait, mobility, and balance confidence for individuals with Parkinson's Disease? 2. Does incorporating a personalized gait training video alongside cognitive cueing lead to amplified improvements in gait, mobility, and balance confidence for individuals with Parkinson's Disease?
Researchers will compare how gait, mobility, balance confidence and quality of life change over time for participants when they practice walking with and without a cognitive cue alone, and when they practice with using a personalized gait training video.
The researchers are also interested in how participation in this trial will affect quality of life and conscious attention to gait.
Participants will
* Complete walking trials on an instrumented mat that records data on their walking ability. These trials will be undertaken without a cognitive cue and while participants mentally rehearse a series of 3 cognitive cues (Take big long steps; Walk heel-toe; Stand up straight). * Be informed about which of the 3 cues best improved their walking and will receive a personalized gait training video for at home practice. * Complete online surveys that ask questions about their Parkinson's Disease, mobility, balance confidence quality of life and conscious attention to gait. * Visit the research facility 3 to 4 times during the study to have their gait (walking), mobility, balance confidence, quality of life and conscious attention to gait assessed and reassessed. * Practice both with and without their personalized video at home and keep a diary to record their practice sessions * Participate in a brief interview to discuss their experiences with the training and their perceptions of the effectiveness of cognitive cues and video-recorded feedback
Trial opening soon.
Get Notified40 year–99 year
All sexes
Interventional
Not applicable
London, Ontario, N6A 3K7, Canada
Administrative Assistant, Western Centre for Brain & Mind
CONTACT
(519) 661-2111 ext. 86057
Jessica A Grahn
PRINCIPAL_INVESTIGATOR
Research Facility Manager
CONTACT
519-661-211 ext. 87988
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized gait training videos featuring cued and non-cued gait for participants
A verbal cue to be mentally rehearsed by each participant
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Mean of stride length measured in centimeters (cm).
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Coefficient of variation in stride length.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Mean of stride width measured in centimeters (cm).
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Coefficient of variation in stride width.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Mean of stride velocity measured in centimeters per second-squared (cm/s^2).
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Coefficient of variation in stride velocity.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Mean double support time measured as a proportion (0-1). This is the proportion of a gait cycle spent with two feet on the ground.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Coefficient of variation in double support time
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
Timed test of functional mobility where participants are recorded on the number of seconds it takes to stand up from a chair, walk 10ft, turn around, walk back 10ft, and sit back in the chair. Longer times suggest lower functional mobility.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
16-item self-report scale where participants rate their confidence on items using 0 to 100 scale. The scale score is the mean of all items, with a maximum of 100 and minimum of 0. Higher score indicate greater balance confidence.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
11-item self-report scale where participants rate the frequency that they experience the scenarios described by the items on a 5pt Likert scale (0- not all all, 5 - very much so). Scores are calculated on the followings 4 sub-scales ( Anxiety [/15], Conscious movement processing[/15], Fall-related ruminations[/10], Processing efficiency[/10]). Lower sum scores for Anxiety, Fall related ruminations and Processing efficiency indicate better outcomes. Higher sum score for Conscious movement processing indicate greater attention is focused on walking.
Time frame: From baseline to the end of the study (~17 weeks after baseline) as follows: Week 0 (Baseline), Week 5 (Session 2); Week 9 (Session 3 Video Delay Group ONLY); Week 13 (Session 3 Video Start Group ONLY); Week 17 (Session 4 Video Delay Group ONLY)
39-item self-report scale designed to evaluate quality of life of people with Parkinson's Disease across 8 dimensions of daily living. Participants rank items on a 5pt Likert scale (0 - never, 4 - always). Higher scores in each dimension's sub-scale and the scale as a whole indicate a poorer quality of life.
Time frame: At baseline only
11 items/tasks administered to measure participant's cognitive abilities and screen for potential cognitive impairment. The final score is out of 30 total pts where higher scores indicate greater cognitive function.
Contact information is provided by the study sponsor or research team.
Western University, Canada
Other
Investigating the Longitudinal Efficacy of Cognitive Cueing and Video Intervention for Gait in People With Parkinson's Disease
Acronym: CogCueVidPD
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