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Clinical Trials/NCT05551338
NCT05551338
Recruiting
Not Applicable

Serious Games for Parkinson's Disease

Rutgers, The State University of New Jersey1 site in 1 country20 target enrollmentJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Rutgers, The State University of New Jersey
Enrollment
20
Locations
1
Primary Endpoint
Montreal Cognitive Assessment (MoCA)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Francois Daneault, Ph.D.

Assistant professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MoCA)

Time Frame: 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 Outcomes

  • PDQ-39(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
  • Digit span forward and backward(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
  • LifeSpace Assessment(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))
  • Sensor-based mobility(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))

Study Sites (1)

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