Serious Games for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Serious Games for Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551338
• Other study ID #: Pro2020002765
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Jean-Francois Daneault
• Phone: 9739728482
• Email: jf.daneault[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of mild to moderate PD (Hoehn & Yahr 1-3)

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:

1. comorbid conditions that could affect the performance of the tasks (e.g. severe uncorrected vision impairment)

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

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Rutgers University	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)