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

NCT06894030 | Not Yet Recruiting

• 1 other identifier: HSREB125635
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Gait; Cueing; Balance; Mobility

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• 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

Study Arms (2)

Video Start

EXPERIMENTAL

Behavioral: Gait Training Video; Behavioral: Cognitive Cue

Video Delay

EXPERIMENTAL

Behavioral: Gait Training Video; Behavioral: Cognitive Cue

Interventions

Gait Training Video BEHAVIORAL

Personalized gait training videos featuring cued and non-cued gait for participants

Video Delay; Video Start

Cognitive Cue BEHAVIORAL

A verbal cue to be mentally rehearsed by each participant

Video Delay; Video Start

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Deep Brain Stimulation (DBS) implant
• Standardized Mini Mental State Examination (SMMSE) score less than 24

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Centre for Brain and Mind, Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sarah V Park

CONTACT

(902) 300 9488; spark822@uwo.ca

Jeffrey Holmes

CONTACT

jholme@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Occupational Therapy

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)