Serious Games for Parkinson's Disease

NCT05551338 | Unknown

• 1 other identifier: Pro2020002765
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Parkinson

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (6)

• Digit span forward and backward

  Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)

• Semantic fluency test

  Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)

• Geriatric depression scale

  Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)

• LifeSpace Assessment

  Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)

• PDQ-39

  Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Serious games

Control

NO INTERVENTION

Patients will undergo only their conventional care

Interventions

Serious games OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

Newark, New Jersey, 07107, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Jean-Francois Daneault

CONTACT

9739728482; jf.daneault@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participant assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: September 22, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will become available after study completion. Data availability will be indefinite as it will be posted on a data repository.

Locations

US (1)