Serious Games for Parkinson's Disease

Study Overview
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Brief Summary
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IMPORTANCE: Rehabilitation games have been shown to improve cognitive function among people with various disorders but they have not been explored in home settings for patients with Parkinson's disease. OBJECTIVE: To collect pilot data regarding the therapeutic benefits of self-administered rehabilitation games among patients with Parkinson's disease. METHODS: The investigators will recruit 20 patients with Parkinson's disease into a pilot randomized controlled trial. Patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in addition to conventional care or undergo only usual care. Patients will be evaluated at baseline, after 12 weeks of treatment, and at 24 weeks. Improvements in cognitive function, depression, quality of life, and mobility will be assessed. RELEVANCE: Identifying whether self-administered rehabilitation games can lead to clinical improvements could have significant implications for the management of the disease.

Official Title
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Serious Games for Parkinson's Disease

Conditions
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Parkinson Disease, Parkinson

Intervention / Treatment
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* Other: Serious games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mild to moderate PD (Hoehn & Yahr 1-3) baseline MoCA score <26 ≥ 18 years-old ability to communicate and read in English have self-reported technological literacy (ie answer yes to the question asking if they are comfortable using technological devices) Exclusion Criteria: comorbid conditions that could affect the performance of the tasks (e.g. severe uncorrected vision impairment) severe cognitive impairment that would prevent the patient from understanding the tasks (MoCA<16) if the subject does not want to be video recorded during the assessments or interview sessions if the subject does not have access to WiFi

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: 10 patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in addition to their conventional care. Group 2: 10 patients will only receive their conventional care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in their home setting in addition to their conventional care | Other: Serious games<br>* The training protocol will entail using a tablet-based program that includes 6 serious games. Patients will be asked to use the program twice a week for 3 months. The serious games that will be used in this study were developed to challenge short-term memory and selective attention in six different games. Each of the six games comprise 20 different stages of varying difficulty, where stage 1 is the easiest and stage 20 is the most difficult.<br>|
| No Intervention: Control<br>Patients will undergo only their conventional care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The minimum score is 0 the maximum score is 30. Higher scores indicate higher cognitive function and lower scores indicate lower cognitive function. | Baseline (week 0) | 
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The minimum score is 0 the maximum score is 30. Higher scores indicate higher cognitive function and lower scores indicate lower cognitive function. | Post-intervention (week 12) | 
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The minimum score is 0 the maximum score is 30. Higher scores indicate higher cognitive function and lower scores indicate lower cognitive function. | Follow-up (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digit span forward and backward | These tests are used to measure working memory's number storage capacity. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) | 
| Semantic fluency test | This verbal fluency test has been shown to be effective in measuring executive functioning and language ability because the semantic/category subtest seems to require a higher level of thought processes since people have to think of meaning. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) | 
| Geriatric depression scale | The geriatric depression scale is a self-report measure of depression in older adults. The minimum score is 0 and the maximum score is 15. Higher scores indicate greater severity of depressive symptoms and lower scores indicate lesser severity of depressive symptoms. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) | 
| LifeSpace Assessment | The LifeSpace Assessment assesses mobility from the spaces that older adults go, and how often, and how independently they move. The minimum score is 0 and the maximum score is 120. Higher scores indicate a larger life space and lower scores indicate a smaller life space. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) | 
| PDQ-39 | It is a self-administered questionnaire to assess PD-specific health-related quality of life. The 39-item self-report questionnaire will be used to asses quality of life. The questionnaire has 8 domains (e.g. mobility, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort). It contains questions asking how often certain difficulties/problems have occurred within the last month with answers ranging from never to always. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Higher scores indicate poorer quality of life and lower scores indicate higher quality of life. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) | 
| Sensor-based mobility | Wearable sensor data features will be extracted from the data such as active and sedentary time, gait speed, and others. | Baseline (week 0), Post-intervention (week 12), Follow-up (week 24) |