A Mobile Application for Telerehabilitation in Parkinson’s Disease

You are invited to participate in a research study because you have Parkinson’s disease (PD). The purpose of this study is test whether a 12‐week exercise program using the 9zest exercise app for PD is safe and feasible and can help improve your symptoms.

Recruitment Information:

Seeking volunteers with following diagnosis: PD, Control Volunteers Accepted Study Type: Observational
Eligible Ages: 40 - 75 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus: Bradykinesia (slowness of movement), rigidity, Dyskinesia, Gait disturbances (e.g., freezing), Postural Instability (falling)

Study Purpose:

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More Details

Study design. We 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 they answer yes to the invitation they will be consented through a questionnaire in the app. In the consent form for participation, prospective participants will learn the eligibility criteria. If they complete the informed consent process, they will then be required to answer specific inclusion and exclusion criteria questions to ensure that they qualify 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. The specific eligibility criteria are the following: 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 DBS 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. Outcome measurements. After completing the consent process and prior to participation in the 12-week trial, participants will answer several questions about their specific symptoms to complete their registration and profile. They will then be asked to perform a couple of outcome measures for their pre-test via the app. Participants will also be tested at the 4 week, 8 week, and 12 week marks. The Primary Endpoints of safety and feasibility will all be assessed via the app: Safety Adverse event reporting – Every two weeks, users will be asked if they have experienced any exercise-related adverse events via questionnaire. Falls – Users will be asked if they experienced a fall during each of their exercise sessions. If yes, additional questions will be asked to characterize the severity/cause of the fall. Feasibility/Usability (8 and 12 week points) Usability – Likert scale questionnaire examining ease of use, design, user friendliness Feasibility – App use frequency and adherence to instructions The Secondary Endpoints (signal of efficacy) will likewise be assessed via the app and will be assessed at the 4 week, 8 week, and 12 week points: 30 second Sit-To-Stand – Functional lower extremity strength Timed Up and Go – Mobility, balance, walking ability and fall risk PDQ-39, mobility scale – PD-specific health related quality of life; 10 questions 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 our 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, they have all been deemed to be safe by physical therapists for their 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, we will likely sort and analyze the data based on compliance (eg, high engagers, moderate engagers, low engagers). Primary Endpoints (most primary endpoints will be tabulations of events and information derived from usage of the app from the app itself; the only primary endpoint that is an actual instrument is the Post Intrinsic Motivation Inventory). Safety Adverse event reporting – Every two weeks, users will be asked if they have experienced any exercise-related adverse events via questionnaire. Falls – Users will be asked if they experienced a fall during their exercise session. If yes, additional questions will be asked to characterize the severity/cause of the fall. Feasibility/Usability Usability – Likert scale questionnaire examining ease of use, design, user friendliness (Post Intrinsic Motivation Inventory) Feasibility – App use frequency and adherence to study protocol Secondary Endpoints (Results at 8 weeks will be compared to baseline performance) Signal of Efficacy 30 second Sit-To-Stand – Functional lower extremity strength Timed Up and Go – Mobility, balance, walking ability and fall risk PDQ-39, mobility scale – PD-specific health related quality of life (MDS-UPDRS)

Phase: Observational Lead Sponsor: 9zest, Inc.
Trial ID: 005171 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors: University of Nevada, Las Vegas & Boston University
Estimated Enrollment: 300 Study Start Date: February 2018
Estimated Study Completion Date: December 2018 Source:
Study Website: 9zest.com/parkinsons-research

More Inclusion & Exclusion Criteria

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