Cognitive Cueing + Video Intervention for Parkinson's Disease

(CogCueVidPD Trial)

Overseen By Sarah V Park

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Deep brain stimulation, SMMSE < 24, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 17 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on walking and cognitive cues, so you may not need to change your medication routine.

Is the Cognitive Cueing + Video Intervention safe for humans?

The studies suggest that computerized cognitive training and technological visuo-cognitive training are generally safe for people with Parkinson's disease, as they focus on non-drug interventions and have been evaluated for safety and acceptability in home settings. ^{1 2 3 4 5}

How does the Cognitive Cue treatment differ from other treatments for Parkinson's disease?

Cognitive Cue treatment is unique because it focuses on enhancing motivation and cognitive control in Parkinson's disease patients, which is different from traditional treatments that primarily address motor symptoms. This approach leverages the enhanced incentive motivation observed in Parkinson's patients to improve cognitive deficits, offering a novel strategy compared to standard therapies. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Cognitive Cue, Gait Training Video for Parkinson's Disease?

Research shows that cognitive training can improve cognitive function in Parkinson's patients, and goal-based rehabilitation that uses attention strategies can enhance motor function. These findings suggest that combining cognitive cueing with gait training may help improve both cognitive and motor skills in Parkinson's patients. ^{1 6 10 11 12}

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are interested in improving their walking, mobility, and balance confidence. Participants will be asked to complete walking trials, use a personalized gait training video at home, fill out online surveys about their condition and experiences, and visit the research facility several times.

Inclusion Criteria

Fluent in English

I have been diagnosed with Parkinson's Disease.

I don't have brain-related health issues like tumors or recent injuries.

Exclusion Criteria

Presence of Deep Brain Stimulation (DBS) implant

Standardized Mini Mental State Examination (SMMSE) score less than 24

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete initial walking trials and online surveys to assess gait, mobility, balance confidence, and quality of life

1 week

1 visit (in-person)

Treatment

Participants practice cognitive cueing and personalized gait training video at home, with periodic assessments at the research facility

17 weeks

3-4 visits (in-person)

Follow-up

Participants are monitored for changes in gait, mobility, balance confidence, and quality of life after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Cue
• Gait Training Video

Trial Overview The study tests if cognitive cueing (thinking about specific walking techniques) alone or combined with a personalized gait training video can enhance gait and mobility in Parkinson's patients. It compares changes over time in participants' walking ability when using these methods separately or together.

How Is the Trial Designed?

Group I: Video Start Experimental Treatment 2 Interventions

Group II: Video Delay Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

A novel client-centered cognitive strategy training intervention for people with Parkinson's disease (PD) was found to be feasible and well-accepted, with high participant satisfaction and engagement scores.

The intervention showed promising effects on self-identified cognitive problems, with significant improvements in functional ratings measured by the Canadian Occupational Performance Measure (COPM) after treatment sessions lasting an average of 9.2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. Foster, ER., Spence, D., Toglia, J.[2019]

Computerized cognitive training (CCT) has been shown to provide small but statistically significant improvements in overall cognitive function for people with Parkinson's disease, particularly benefiting those with mild cognitive impairment (PD-MCI).

The study analyzed 17 trials with 679 participants and found that greater doses of CCT were linked to larger cognitive benefits, indicating that CCT can be effective even when delivered remotely, but more extensive trials are needed to determine the best training regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in Parkinson's disease: A systematic review and meta-analysis. Gavelin, HM., Domellöf, ME., Leung, I., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive training in Parkinson disease: A systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Focused and Sustained Attention Is Modified by a Goal-Based Rehabilitation in Parkinsonian Patients. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Enhanced motivation of cognitive control in Parkinson's disease. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in Parkinson's disease: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Exploring the feasibility of technological visuo-cognitive training in Parkinson's: Study protocol for a pilot randomised controlled trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

An evaluation of self-administration of auditory cueing to improve gait in people with Parkinson's disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Thinking about motor fluctuations: An examination of metacognitions in Parkinson's disease. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Virtual cues and functional mobility of people with Parkinson's disease: a single-subject pilot study. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of visual, auditory, and mixed cues on choice reaction in Parkinson's disease. [2008]

11. England pubmed.ncbi.nlm.nih.gov

Event-related potentials associated with covert orientation of visual attention in Parkinson's disease. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Voluntary and automatic visual spatial shifts of attention in Parkinson's disease: an analysis of costs and benefits. [2008]