Clinical trial NCT05551338: Serious Games for Parkinson's Disease
Official title: Serious Games for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Parkinson
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (week 0)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Post-intervention (week 12)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Follow-up (week 24)
Secondary outcomes:
measure: Digit span forward and backward
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
measure: Semantic fluency test
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
measure: Geriatric depression scale
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
measure: LifeSpace Assessment
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
measure: PDQ-39
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
measure: Sensor-based mobility
timeFrame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References: