Serious Games for Parkinson's Disease
Primary Purpose
Parkinson Disease, Parkinson
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serious games
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Rutgers UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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
Patients will undergo only their conventional care
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Digit span forward and backward
These tests are used to measure working memory's number storage capacity.
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.
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.
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.
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.
Sensor-based mobility
Wearable sensor data features will be extracted from the data such as active and sedentary time, gait speed, and others.
Full Information
NCT ID
NCT05551338
First Posted
June 21, 2022
Last Updated
September 19, 2022
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05551338
Brief Title
Serious Games for Parkinson's Disease
Official Title
Serious Games for Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinson
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to participant assignment.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will undergo only their conventional care
Intervention Type
Other
Intervention Name(s)
Serious games
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Baseline (week 0)
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Post-intervention (week 12)
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Follow-up (week 24)
Secondary Outcome Measure Information:
Title
Digit span forward and backward
Description
These tests are used to measure working memory's number storage capacity.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Title
Semantic fluency test
Description
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.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Title
Geriatric depression scale
Description
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.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Title
LifeSpace Assessment
Description
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.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Title
PDQ-39
Description
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.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Title
Sensor-based mobility
Description
Wearable sensor data features will be extracted from the data such as active and sedentary time, gait speed, and others.
Time Frame
Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Francois Daneault
Phone
9739728482
Email
jf.daneault@rutgers.edu
Facility Information:
Facility Name
Rutgers University
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Daneault
Phone
973-972-8482
Email
jf.daneault@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Following the completion of this study, the deidentified data set resulting from this body of work will be added to an open source data bank for use by future researchers.
IPD Sharing Time Frame
The data will become available after study completion. Data availability will be indefinite as it will be posted on a data repository.
Learn more about this trial
Serious Games for Parkinson's Disease
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