Clinical trial NCT06894030: Cognitive Cueing and Video Intervention for Gait in Parkinson's Disease
Official title: Investigating the Longitudinal Efficacy of Cognitive Cueing and Video Intervention for Gait in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Gait
Cueing
Balance
Mobility
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Mean Stride Length
timeFrame: 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)
measure: Variability iin Stride Length
timeFrame: 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)
measure: Mean of Stride Width
timeFrame: 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)
measure: Variability in Stride Width
timeFrame: 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)
measure: Mean of Stride Velocity
timeFrame: 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)
measure: Variability in Sride Velocity
timeFrame: 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)
measure: Mean of Double Support Time
timeFrame: 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)
measure: Variability in Double Support Time
timeFrame: 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)
measure: Timed Up and Go (TUG)
timeFrame: 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 outcomes:
measure: Activities-specific Balance Confidence Scale (ABC)
timeFrame: 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)
measure: Gait-Specific Attentional Profile (G-SAP)
timeFrame: 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)
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: 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)
measure: Standardized Mini Mental State Examination (SMMSE)
timeFrame: At baseline only
Other outcomes:
Locations:
city: London
country: Canada
facility: Centre for Brain and Mind, Western University
state: Ontario
Study officials:
References: