Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-06-15
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 2: 10 patients will only receive their conventional care.
TREATMENT
SINGLE
Study Groups
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Intervention
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
Serious games
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.
Control
Patients will undergo only their conventional care
No interventions assigned to this group
Interventions
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Serious games
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.
Eligibility Criteria
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Inclusion Criteria
2. baseline MoCA score \<26
3. ≥ 18 years-old
4. ability to communicate and read in English
5. have self-reported technological literacy (ie answer yes to the question asking if they are comfortable using technological devices)
Exclusion Criteria
2. severe cognitive impairment that would prevent the patient from understanding the tasks (MoCA\<16)
3. if the subject does not want to be video recorded during the assessments or interview sessions
4. if the subject does not have access to WiFi
18 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Jean-Francois Daneault, Ph.D.
Assistant professor
Locations
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Rutgers University
Newark, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro2020002765
Identifier Type: -
Identifier Source: org_study_id
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