Parkinson's DiseaseCogCueVidPDNCT06894030
Cognitive Cueing and Video Intervention for Gait in Parkinson's Disease
A study testing Gait Training Video and Cognitive Cue in people with Parkinson's Disease, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Gait Training Video and Cognitive Cue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Deep Brain Stimulation (DBS) implant
- Standardized Mini Mental State Examination (SMMSE) score less than 24
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeffrey Holmes contact
Canada1 site
Centre for Brain and Mind, Western University
London, Ontario, N6A 3K7
Administrative Assistant, Western Centre for Brain & Mind, (519) 661-2111 ext. 86057, dsoanes4@uwo.ca
Research Facility Manager, 519-661-211 ext. 87988, dquinla4@uwo.ca
About this study
Official title: 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:
- 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?
Read more
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
- Conditions
- Parkinson's Disease
- Being tested
- Gait Training Video, Cognitive Cue
- Keywords
- Gait, Cueing, Balance, Mobility
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Training VideoBehavioural
Personalized gait training videos featuring cued and non-cued gait for participants
Cognitive CueBehavioural
A verbal cue to be mentally rehearsed by each participant
| Study group | Role | What they receive |
|---|---|---|
| Video Start | Experimental | Not described Receives: Behavioral: Gait Training Video; Behavioral: Cognitive Cue |
| Video Delay | Experimental | Not described Receives: Behavioral: Gait Training Video; Behavioral: Cognitive Cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Stride Length
Mean of stride length measured in centimeters (cm).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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 (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Holmes, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894030
- Sponsor's protocol ID
- HSREB125635
- Acronym
- CogCueVidPD
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Longitudinal Efficacy of Cognitive Cueing and Video Intervention for Gait in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06894030
- Acronym / sponsor ID
- CogCueVidPD / HSREB125635
- Conditions
- Parkinson's Disease
- Keywords
- Gait, Cueing, Balance, Mobility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video Start | Experimental | Behavioral: Gait Training Video, Behavioral: Cognitive Cue |
| Video Delay | Experimental | Behavioral: Gait Training Video, Behavioral: Cognitive Cue |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Deep Brain Stimulation (DBS) implant
- Standardized Mini Mental State Examination (SMMSE) score less than 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Training VideoPersonalized gait training videos featuring cued and non-cued gait for participants | Behavioural | Video Delay, Video Start |
| Cognitive CueA verbal cue to be mentally rehearsed by each participant | Behavioural | Video Delay, Video Start |
Primary outcome
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.
4 secondary outcomes
Activities-specific Balance Confidence Scale (ABC)
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)
Gait-Specific Attentional Profile (G-SAP)
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)
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
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)
Standardized Mini Mental State Examination (SMMSE)
Time frame: At baseline only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Holmes contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training Video and Cognitive Cue in people with Parkinson's Disease, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah V Park ((902) 300 9488, spark822@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.