Serious Games for Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson; Parkinson Disease
• Interventions: Other: Serious games

• Registration Number: NCT05551338
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-06-21
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Serious games	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

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	Follow-up (week 24)	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

Name	Time	Method
Digit span forward and backward	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	These tests are used to measure working memory's number storage capacity.
LifeSpace Assessment	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	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	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	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.
Semantic fluency test	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	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	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	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.
Sensor-based mobility	Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)	Wearable sensor data features will be extracted from the data such as active and sedentary time, gait speed, and others.

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 Newark, New Jersey, United States