Cognitive Cueing and Video Intervention for Gait in Parkinson's Disease (CogCueVidPD)

Investigating the Longitudinal Efficacy of Cognitive Cueing and Video Intervention for Gait in People with Parkinson's Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Gait Training Video; Behavioral: Cognitive Cue

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah V Park; Phone Number: (902) 300 9488; Email: spark822@uwo.ca
• Study Contact Backup: Name: Jeffrey Holmes; Email: jholme@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Centre for Brain and Mind, Western University
      • Contact: Administrative Assistant, Western Centre for Brain & Mind; Phone Number: 86057 (519) 661-2111; Email: dsoanes4@uwo.ca
      • Contact: Research Facility Manager; Phone Number: 87988 519-661-211; Email: dquinla4@uwo.ca
      • Contact: Jessica A Grahn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Start	Behavioral: Gait Training Video; Personalized gait training videos featuring cued and non-cued gait for participants; Behavioral: Cognitive Cue; A verbal cue to be mentally rehearsed by each participant
Experimental: Video Delay	Behavioral: Gait Training Video; Personalized gait training videos featuring cued and non-cued gait for participants; Behavioral: Cognitive Cue; A verbal cue to be mentally rehearsed by each participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Stride Length	Mean of stride length measured in centimeters (cm).	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)
Variability iin Stride Length	Coefficient of variation in 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 Width	Mean of stride width measured in centimeters (cm).	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)
Variability in Stride Width	Coefficient of variation 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)
Mean of Stride Velocity	Mean of stride velocity measured in centimeters per second-squared (cm/s^2).	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)
Variability in Sride Velocity	Coefficient of variation in 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 Double Support Time	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.	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)
Variability in Double Support Time	Coefficient of variation 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)
Timed Up and Go (TUG)	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities-specific Balance Confidence Scale (ABC)	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.	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)	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.	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)	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.	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)	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.	At baseline only

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Gait; Mobility; Cueing
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: HSREB125635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No