Clinical trial NCT03459586: A Mobile Application for Telerehabilitation in Parkinson's Disease
Official title: The Purpose of This Study is to Determine if the 9zest App for Parkinson's Disease (PD) is Feasible, Safe, and Efficacious When Used Independently by Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Lead sponsor: 9zest. Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nevada, Las Vegas
name: Boston University
First posted: 2018-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The purpose of this study is to determine if the 9zest app for Parkinson's disease is feasible, safe, and efficacious when used independently by individuals with Parkinson's disease.
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if the 9zest app for Parkinson's disease is feasible, safe, and efficacious when used independently by individuals with Parkinson's disease.

Detailed description: The investigators will evaluate the 9zest app using a non-randomized, single-group design wherein participants who have downloaded the 9zest app will be informed via a message in the app about the trial and invited to participate. If the participant answers yes to the invitation the participant will be consented through a questionnaire in the app. In the consent form for participation, prospective participants will learn the eligibility criteria. If the participant completes the informed consent process, the participant will then be required to answer specific inclusion and exclusion criteria questions to ensure qualification for the study. A phone number that goes directly to a member of the research team will be provided if the prospective participant has any questions during the informed consent process.

Outcome measurements. After completing the consent process and prior to participation in the 12-week trial, participants will answer several questions about specific symptoms to complete their registration and profile. The participant will then be asked to perform a couple of pretest outcome measures via the app. Participants will also be tested at the 4 week, 8 week, and 12 week marks.

Exercise intervention. The 12-week app guided exercise intervention is a personalized exercise regimen. Participants will use the smartphone/tablet app for the study period of 12 weeks. While the app has been developed to deliver physical therapy in a variety of movement disorders including multiple system atrophy, progressive supranuclear palsy, and dementia with Lewy bodies, users will choose the PD track for the purposes of the study, which is the population of interest. The participants will create a PD profile with a series of questions to assess the current level of functioning. A proprietary algorithm (9zest Smart™) developed by physical therapists and information technologists chooses the appropriate workout regimen for the person's level of function. The customized regimen is intended to be safe and effective for the participant. The 9zest App Family has over 1,000 original therapy videos in its library, which encompasses Physical Therapy, Fitness, Yoga, Meditation, and Speech Therapy. 9zest Smart™, the app's intelligent engine determines the right set and levels of exercises for a user based on the Smart Assessment responses. At preset intervals (generally after 2 weeks), the app will again assess the user's functional capacity and needs. Again, the 9zest Smart algorithm will adjust the type, duration, and intensity of the regimen to maximize performance. All of the exercises and dosing features are consistent with contemporary and evidence-based physical therapy practice. Additionally, the exercises have all been deemed to be safe by physical therapists for each particular level of function. The exercise program is imbedded in the app. A demonstration of the exercise is shown in audiovisual format and then the participant follows along with the exercise in real time.

Participants in the trial will be asked to participate in the 12-week exercise program with the goal of participating 3 times per week with each session lasting 60 minutes. After the trail is over, the investigators will sort and analyze the data based on compliance (eg, high engagers, moderate engagers, low engagers).

Eligibility criteria: 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
* Willingness to participate is a 12 week study
* Be able to stand unassisted for 10 minutes
* Stable on PD medication and deep brain stimulation for 3 months prior to trial

Exclusion Criteria:

* Failure on a cognition screen
* Co-morbidities that would preclude exercise participation or increase participant risk: severe osteoarthritis/pain, stroke, severe respiratory problems, traumatic brain injury, neuromuscular disease, atrial fibrillation, poorly controlled cardiovascular disease, limb amputation, osteoporosis)
* Vision or hearing impairment that would interfere with app use
* Fall that required physician evaluation (ED, urgent care, hospitalization) with the past year
* Use of an assistive device (or person) for walking, standing, balance.
* Currently use of a structured exercise regimen defined as participation in a regular exercise program consisting of more than 60 minutes per week in total

Primary outcomes:
measure: Incidence of adverse events and falls during exercise using the 9 zest app
timeFrame: 12 week measurement point
measure: Self-report questionnaire on the feasibility and usability of exercising using the 9 zest app
timeFrame: 12 week measurement point
Secondary outcomes:
measure: The change in the number of times a participant can go from sitting to standing in 30 seconds
timeFrame: Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
measure: The change in the amount of time a person can go from a sitting position to walking 3 meters, turning around and going back to sitting.
timeFrame: Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
measure: The change in score on a self-report questionnaire of quality of life regarding mobility
timeFrame: Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Merrill Landers
state: Nevada
Study officials:
affiliation: UNLV, Las Vegas
name: Merrill Landers, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landers MR, Ellis TD. A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy. JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e18985. doi: 10.2196/18985.