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Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03835611
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date April 17, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
Retention to GTP [ Time Frame: 1 year ]
Percentage of participants adhering to 10 Weeks of GTP protocol.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03835611 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
Sample size calculation [ Time Frame: 1 Year ]
Power calculation will be done with coefficient of variation of step length during DT walking as primary outcome measure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease
Official Title  ICMJE Evaluating the Use of a Cognitive Game-Based Treadmill Exercise Program to Improve Balance and Gait in People With Parkinson Disease: A Feasibility Randomized Controlled Trial
Brief Summary An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT.
Detailed Description

Parkinson's disease (PD) is the second most commonly occurring neurological disorder in Canada, affecting approximately 99,000 individuals, and the number is expected to grow to 140,000 individuals by the year 2025. The hallmark of PD pathology is a progressive degeneration of dopaminergic neurons in the basal ganglia (BG). Therefore, there is a significant deterioration of balance and gait function, and especially when concurrently performing a cognitive task (dual-task walking). Fifty percent of individuals with PD also show deficiencies in one or more cognitive area. In addition, up to 80% of PD patients eventually develop dementia. Over 60% of PD, individuals fall each year and a significant portion of those who fall will experience multiple falls. Most falls occur during walking, and the consequences of these falls are often severe, leading to disability, loss of independence (i.e. safe community ambulation). For individuals with PD, community ambulation is strongly associated with the preservation of skills for independent living, leisure/recreational activities, social participation and healthy aging. Daily activities afford numerous situations in which walking must be combined with a cognitive task, such as, navigation, negotiating terrains and obstacles, tracking visual targets, reading, and recall. Walking and cognitive abilities are closely linked, and several studies have demonstrated that walking while performing various cognitive tasks (dual-task walking) results in greater gait disturbances, threats to stability and provokes freezing of gait in PD.

Numerous studies have shown that modest levels of physical activity and targeted physical therapy improves muscle strength, balance, mobility and reduces the risk of falls among older adults. Several studies have also shown improved cognitive function with physical activity, and others report that interventions that enhance cognitive skills led to improvements in fall risk. Because physical and executive cognitive decline both contribute to mobility limitations and an increased fall risk with age, several PD researchers and clinicians have developed balance-walking programs augmented with interactive cognitive activities (Dual-task training). Maximizing participation is also seen as a main goal of interventions. Long-term exercise/training programs are often fraught with low compliance and adherence. An emerging methodology is to combine exercise and activities with computer games, making the training experience more engaging and enjoyable. This approach can be an important tool for rehabilitation because it has the potential to increase participation and exercise adherence. Importantly digital media in the form of computer games can also challenge and train many different aspects of executive cognitive function. For example, many computer games are now readily available in which processing speed, cognitive inhibition, task switching, working memory and problem solving are the main components of the interactive game events.

Based on this information, investigators have has developed and validated an engaging, game-based treadmill platform (GTP), which provides an integrated approach to treat and assess the decline in balance, mobility, Visuomotor and visuospatial executive cognitive function. The GTP consists of 1) a standard treadmill instrumented with a pressure mapping system which to compute several spatiotemporal gait variables and gait stability measures; 2) an innovative interactive computer game subsystem for dual-tasking; and 3) an automated monitoring application which uses advanced data logging and analysis method to record the client's actions and choices while walking and playing targeted cognitive games. Therefore, physical and cognitive performance during exercise can be monitored synchronously and quantified electronically. Proof of principle has been established for the use of the GTP in assessment and treatment of older adult's age70-80 with fall history.

Purpose of this exploratory study is to assess the potential for successful implementation of the novel intervention, predict the feasibility and acceptability of the dual-task exercise program and identify unpredicted harm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Other: Game based treadmill Platform

    The protocol for the intervention group will be:

    • Warm up exercised consisting of rhythmical large movements (10minutes)
    • Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes)
    • DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)
  • Other: Control Group
    • Warm-up exercise consisting of rhythmical large movements (10 minutes).
    • Core standing balance exercises on a sponge surface (10 minutes).
    • Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill
    • Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes).
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables "real-time" movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free.
    Intervention: Other: Game based treadmill Platform
  • Active Comparator: Control Group
    Control group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be:
    Intervention: Other: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age range 55-70
  • Diagnosed with PD according to UK brain bank criteria,
  • PD stage 1-3 on Hoehn and Yahr scale,
  • On stable medications for PD from past 3months,
  • Able to walk 50m independently,
  • Montreal Cognitive Assessment( MoCA) score of more than 21(Non-Dementia PD).

Exclusion Criteria:

  • Any other neurodegenerative condition,
  • Any orthopedic or cardiovascular impairment limiting independent walking for a minimum of 10 minutes.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bhuvan Mahana 4319971771
Contact: Tony Szturm
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03835611
Other Study ID Numbers  ICMJE H2018:338
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No discussion yet.
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Manitoba
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP