Parkinson DiseaseNCT05551338
Serious Games for Parkinson's Disease
A study testing Serious games in people with Parkinson Disease and Parkinson, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson
- What is being tested?
- Serious games
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
Newark, New Jersey, 07107
Jean-Francois Daneault, 973-972-8482, jf.daneault@rutgers.edu
About this study
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.
Read more
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
- Being tested
- Serious games
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Serious games |
| Control | No intervention | Patients will undergo only their conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Follow-up (week 24)
Secondary outcomes (6)
Digit span forward and backward
These tests are used to measure working memory's number storage capacity.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Semantic fluency test
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.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Geriatric depression scale
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.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
LifeSpace Assessment
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.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
PDQ-39
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.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Sensor-based mobility
Wearable sensor data features will be extracted from the data such as active and sedentary time, gait speed, and others.
Measured: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551338
- Sponsor's protocol ID
- Pro2020002765
- Status last verified
- Sep 2022
- First submitted
- 21 Jun 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the completion of this study, the deidentified data set resulting from this body of work will be added to an open source data bank for use by future researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Games for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05551338
- Acronym / sponsor ID
- Pro2020002765
- Conditions
- Parkinson Disease, Parkinson
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Serious gamesPatients 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 |
| Control | No intervention | –Patients will undergo only their conventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious gamesThe 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. | Other | Intervention |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (week 0)
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.
Montreal Cognitive Assessment (MoCA)
Time frame: Post-intervention (week 12)
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.
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.
6 secondary outcomes
Digit span forward and backward
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Semantic fluency test
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Geriatric depression scale
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
LifeSpace Assessment
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
PDQ-39
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Sensor-based mobility
Time frame: Baseline (week 0), Post-intervention (week 12), Follow-up (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Yes. Following the completion of this study, the deidentified data set resulting from this body of work will be added to an open source data bank for use by future researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious games in people with Parkinson Disease and Parkinson, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Francois Daneault (9739728482, jf.daneault@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: Baseline (week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.