Investigating the Longitudinal Efficacy of Cognitive Cueing and Video Intervention for Gait in People with Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Stride Length
Study Overview
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:
- Does focusing on cognitive cues while walking improve gait, mobility, and balance confidence for individuals with Parkinson's Disease?
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Video Start
Intervention: Gait Training Video (Behavioral)
Video Start
Intervention: Cognitive Cue (Behavioral)
Video Delay
Intervention: Gait Training Video (Behavioral)
Video Delay
Intervention: Cognitive Cue (Behavioral)
Outcomes
Primary Outcomes
Mean 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 length measured in centimeters (cm).
Variability iin 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)
Coefficient of variation in stride length.
Mean of 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 width measured in centimeters (cm).
Variability 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)
Coefficient of variation in stride width.
Mean of 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 of stride velocity measured in centimeters per second-squared (cm/s\^2).
Variability in Sride 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)
Coefficient of variation in stride velocity.
Mean of 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)
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
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
Timed Up and Go (TUG)
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.
Secondary Outcomes
- 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))
- 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))
- 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))
- Standardized Mini Mental State Examination (SMMSE)(At baseline only)
Investigators
Jeffrey Holmes
Associate Professor, School of Occupational Therapy
Western University, Canada