Parkinson's Disease
Conditions
Keywords
Gait, Cueing, Balance, Mobility
Brief summary
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
Interventions
BEHAVIORALGait Training Video
Personalized gait training videos featuring cued and non-cued gait for participants
BEHAVIORALCognitive Cue
A verbal cue to be mentally rehearsed by each participant
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The Video Start group will receive their gait training video once the intervention begins. The Video Delay group will receive their gait training video after a 4-week delay.
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Be diagnosed with Parkinson's Disease * Be fluent in English * Be able to walk independently and without a walking aid for at least 10 minutes * Have no other cognitive or neurological impairments (e.g., brain tumours, recent concussion, stroke, brain injury)
Exclusion criteria
* Deep Brain Stimulation (DBS) implant * Standardized Mini Mental State Examination (SMMSE) score less than 24
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) | 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. |
| Mean of Stride Velocity | 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). |
| Variability in Sride Velocity | 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. |
| Mean of Double Support Time | 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. |
| Variability in Double Support Time | 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 |
| Mean Stride Length | 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). |
| Variability iin Stride Length | 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. |
| Mean of Stride Width | 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). |
| Variability in Stride Width | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait-Specific Attentional Profile (G-SAP) | 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. |
| Parkinson's Disease Quality of Life Questionnaire (PDQ-39) | 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. |
| Standardized Mini Mental State Examination (SMMSE) | 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. |
| Activities-specific Balance Confidence Scale (ABC) | 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. |
Countries
Canada
Contacts
Primary ContactSarah V Park
Backup ContactJeffrey Holmes
Outcome results
None listed