Recruiting

Serious Games

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05551338

Conditions

Parkinson Disease

Parkinson

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Serious games

Study Details

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

Study ID

NCT05551338

Start date

Jun 15, 2022

Status verified date

Sep, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Control

Patients will undergo only their conventional care

Interventions

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.

Primary outcome measure

  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline (week 0) ]
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Post-intervention (week 12) ]
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Follow-up (week 24) ]

Central Contacts and Locations

Central contacts

Jean-Francois Daneault

9739728482jf.daneault@rutgers.edu

Locations

Rutgers University

Recruiting

Newark, New Jersey, United States, 07107

Contacts

Jean-Francois Daneault

973-972-8482jf.daneault@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Sep 22, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2022-09-22.