Mobile App for Parkinson's Disease

Overseen By Merrill Landers, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 9zest. Inc.

Must be taking: PD medication

Disqualifiers: Severe osteoarthritis, Stroke, Neuromuscular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called 9zest to determine if it helps people with Parkinson's disease exercise safely and effectively at home. The app provides exercises designed by physical therapists, tailored to match a person's abilities and Parkinson's status. It is intended for individuals diagnosed with Parkinson's who can stand unassisted for 10 minutes and have been stable on their medication for three months. Participants will use the app to perform exercises three times a week for 12 weeks. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance at-home exercise for Parkinson's patients.

Will I have to stop taking my current medications?

The trial requires that participants have been stable on their Parkinson's disease medication and any deep brain stimulation for at least 3 months before joining. This means you should not change your current medications if you want to participate.

What prior data suggests that the 9zest app is safe for individuals with Parkinson's disease?

Research has shown that the 9zest app is safe for people with Parkinson's disease. A recent study with 28 patients found the app both safe and helpful. Participants used the app for exercises over three months without any major safety issues. The app offers video-guided exercises designed by physical therapists, tailored to each person's abilities and Parkinson's condition. Overall, the study suggests that the 9zest app is a safe choice for exercise and rehabilitation for people with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 9zest app for Parkinson's Disease because it offers a unique way to deliver therapy through telerehabilitation. Unlike traditional treatments that often require in-person visits and physical therapy sessions, this app provides exercises tailored to an individual's abilities and Parkinson's status, all from the convenience of home. The app uses an algorithm to adjust exercises for strengthening, balance, range of motion, and endurance, which could make therapy more accessible and personalized. This innovative approach has the potential to make regular exercise more feasible for patients, potentially improving their quality of life.

What evidence suggests that the 9zest app is effective for Parkinson's disease?

Research has shown that the 9zest app, which participants in this trial will use, can benefit people with Parkinson's disease. In a study with 28 patients, the app proved both practical and effective after three months of use. It guides users through exercises designed by physical therapists, tailored to their physical abilities and the stage of their Parkinson's. These exercises focus on building strength, improving balance, increasing flexibility, and boosting endurance. Such activities have shown promise in enhancing physical activity, motor skills, and overall quality of life for people with Parkinson's. This suggests that the app may help manage Parkinson's symptoms effectively. ^{1 3 4 5 6}

Who Is on the Research Team?

Merrill Landers, DPT, PhD

Principal Investigator

UNLV, Las Vegas

Are You a Good Fit for This Trial?

Inclusion Criteria

English speaking men and women between 40 and 75 years old

Neurologist-diagnosed PD

A caregiver who is willing to assist the participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Virtual consent and eligibility assessment

Pretest

Participants complete pretest outcome measures via the app

1 week

Virtual assessment via app

Treatment

Participants engage in a 12-week app-guided exercise intervention

12 weeks

3 sessions per week, 60 minutes each

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Virtual follow-up via app

What Are the Treatments Tested in This Trial?

Interventions

• 9zest app

How Is the Trial Designed?

Group I: 9zest app facilitated exercise Experimental Treatment 1 Intervention

App to facilitate exercises for 3 times a week for 12 weeks. The app includes physical therapist-designed exercises that are modified using an algorithm to the participants physical capabilities and PD status. Exercises include strengthening, balance, range of motion, and endurance type exercise.

Who Is Running the Clinical Trial?

9zest. Inc.

Lead Sponsor

Trials

1

Recruited

300+

University of Nevada, Las Vegas

Collaborator

Trials

81

Recruited

14,700+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33016887/

Single-Cohort Pilot Study on Feasibility, Safety, and Signal ... Objective: To test the feasibility, safety, and signal of efficacy of a mobile app that facilitates exercise for people with Parkinson disease.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573700/

A Mobile App Specifically Designed to Facilitate Exercise ... The main purpose of this study was to test the feasibility, safety, and signal of efficacy of the 9zest app for people with Parkinson disease.

3. mdpi.com mdpi.com/1424-8220/23/7/3396

Mobile App Interventions for Parkinson's Disease, Multiple ... Mobile app interventions are promising to improve outcomes concerning patient's physical activity, motor ability, cognition, quality of life and ...

4. nature.com nature.com/articles/s41531-021-00160-3

How COVID-19 will boost remote exercise-based treatment ... A recent study on 28 PD patients evaluated the App “9zest Parkinson's Therapy & Exercises” and reported it to be both feasible and effective.

5. researchgate.net researchgate.net/publication/343171590_A_mobile_application_specifically_designed_to_facilitate_exercise_in_Parkinson_disease_a_single-cohort_pilot_study_on_feasibility_safety_and_signal_of_efficacy_Preprint

a single-cohort pilot study on feasibility, safety, and signal ... A recent study on 28 PD patients evaluated the App "9zest Parkinson's Therapy & Exercises" and reported it to be both feasible and effective. After 3 months of ...

6. mhealth.jmir.org mhealth.jmir.org/2020/10/e18985/PDF

Single-Cohort Pilot Study on Feasibility, Safety, and Signal Based on these promising data, the 9zest app may be a safe, feasible, and useful technology for people with Parkinson disease as an adjuvant to ...