Clinical trial NCT03835611: Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson Disease,
Balance
Gait
Dual Task walking
Feasibility
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention to GTP
timeFrame: 1 year
Secondary outcomes:
measure: Sample size calculation
timeFrame: 1 Year
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: College of Rehabilitation Sciences, University of Manitoba
state: Manitoba
Study officials:
References: