iPACES for Parkinson's Disease

(iPACES-PD Trial)

Overseen By self-enrollment option www.myipaces.org

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: iPACES LLC

Disqualifiers: Cardiovascular problems, Stroke, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment iPACES for Parkinson's Disease?

Research shows that physical activity can improve both motor and non-motor symptoms in Parkinson's disease, enhancing quality of life. Additionally, combining physical and cognitive exercises, like in the iPACES system, has been shown to improve motor and cognitive outcomes in similar treatments. ^{1 2 3 4 5}

How is the iPACES treatment different from other treatments for Parkinson's disease?

The iPACES treatment is unique because it combines physical and cognitive exercises in an interactive system, which is different from traditional treatments that often focus on either physical or cognitive aspects separately. This approach aims to improve both motor and cognitive functions simultaneously, offering a more holistic benefit for patients with Parkinson's disease. ^{1 3 5 6 7}

Research Team

Bob Gillen, PhD

Principal Investigator

iPACES LLC

Cay Anderson-Hanley, PhD

Principal Investigator

iPACES LLC

Eligibility Criteria

This trial is for people over 50 with mild cognitive impairment or Parkinson's Disease who can commit to a year-long study, exercise 3-5 times weekly for at least 6 months using an under-table elliptical, and are comfortable with English. They need approval from their doctor to exercise and must be able to use touch screens despite any tremors.

Inclusion Criteria

Proficient in English (speaking and reading for completion of interview, surveys, game)

Can provide informed consent

Can participate in testing and read and operate tablet touch screen

Exclusion Criteria

Already exercising at recommended levels

I have a significant history of heart problems.

I have a significant history of stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in neuro-exergaming with iPACES or PACE at home, 3-5 times per week for at least 6 months

6 months

Remote participation

Follow-up

Participants are monitored for cognitive and physical outcomes one month after the main intervention

1 month

Treatment Details

Interventions

• iPACES (interactive Physical and Cognitive Exercise System)
• PACE (Physical and Cognitive Exercise)

Trial Overview The study tests the iPACES system, a neuro-exergaming setup designed for home use that combines physical and cognitive exercises. Participants will engage in these activities remotely using either personal devices or equipment provided by the study.

Participant Groups

Group I: iPACES (interactive Physical and Cognitive Exercise System) Experimental Treatment 1 Intervention

iPACES (interactive Physical and Cognitive Exercise System) involves a "pedal-to-play" neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations.

Group II: PACE (physical and cognitive exercise) Active Control 1 Intervention

PACE (Physical and Cognitive Exercise) involves a "pedal-while-play" experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations.

Who Is Running the Clinical Trial?

iPACES LLC

Lead Sponsor

Trials

2

Recruited

240+

Adirondack Neuropsychological Associates

Collaborator

Trials

2

Recruited

240+

Albany Medical College

Collaborator

Trials

96

Recruited

12,700+

Center for Balance, Mobility & Wellness at Gordon College

Collaborator

Trials

1

Recruited

120+

Pacific Brain Health Center

Collaborator

Trials

2

Recruited

240+

1st Playable Productions

Collaborator

Trials

3

Recruited

270+

Findings from Research

A tablet-based training program for Parkinson's disease patients was successfully tested over 9 months, helping them stay motivated and develop personalized training routines after inpatient treatment.

Patients reported positive aspects such as structured support and Parkinson's specificity, but also suggested improvements for better individualization and flexibility in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized tablet-based training program in the domestic setting following complex treatment of Parkinson's disease-Success factors and barriers]. Wagner, L., Deck, R.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized tablet-based training program in the domestic setting following complex treatment of Parkinson's disease-Success factors and barriers]. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gamified Dual-Task Training for Individuals with Parkinson Disease: An Exploratory Study on Feasibility, Safety, and Efficacy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Physical Activity in Parkinson's Disease: A Mini-Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Methodology of exercise resources development for professionals providing services for people with Parkinson's: a technical report. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Mild cognitive impairment in Parkinson's disease is improved by transcranial direct current stimulation combined with physical therapy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Mind-Body Exercises for Non-motor Symptoms of Patients With Parkinson's Disease: A Systematic Review and Meta-Analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of physical exercise interventions on cognitive function in Parkinson's disease: An updated systematic review and meta-analysis of randomized controlled trials. [2023]