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A Mobile Application for Telerehabilitation in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
9zest app facilitated exercise
Sponsored by
9zest. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Merrill LandersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

9zest app facilitated exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events and falls during exercise using the 9 zest app
At the end of the trial, the investigators will analyze the incidence of exercise-related adverse events and falls that occurred while exercising using the 9 zest app over the course of the study. These adverse events will be self-reported using a questionnaire and will be analyzed using frequencies, means, and measures of variability.
Self-report questionnaire on the feasibility and usability of exercising using the 9 zest app
A 5 point Likert style, self-report questionnaire with 6 items taken from the Intrinsic Motivation Inventory will be used to examine ease of use, design, user friendliness of exercising while using the 9zest app. Each of the 6 items will be reported separately. Scores range from 1 to 5 for each item.

Secondary Outcome Measures

The change in the number of times a participant can go from sitting to standing in 30 seconds
The 30 second Sit-To-Stand test will be used to determine a signal of efficacy for functional lower extremity strength.
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.
The Timed Up and Go Test will be used for a signal of efficacy regarding dynamic gait performance.
The change in score on a self-report questionnaire of quality of life regarding mobility
The Parkinson's Disease Questionnaire-39 mobility subscale has 10 disease-specific mobility-related questions and will be used to determine a signal of efficacy related to disease-specific mobility. Each of the 10 items has a 5 item Likert response with scores ranging from 0 to 4. The scores of all 10 items will be added up and divided by the total possible points (40 points); thus, this outcome measurement will be reported as a percent of the total possible points with a lower score being suggestive of higher mobility-related quality of life.

Full Information

First Posted
February 24, 2018
Last Updated
March 2, 2018
Sponsor
9zest. Inc.
Collaborators
University of Nevada, Las Vegas, Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03459586
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
9zest. Inc.
Collaborators
University of Nevada, Las Vegas, Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
9zest app facilitated exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
9zest app facilitated exercise
Intervention 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 Outcome Measure Information:
Title
Incidence of adverse events and falls during exercise using the 9 zest app
Description
At the end of the trial, the investigators will analyze the incidence of exercise-related adverse events and falls that occurred while exercising using the 9 zest app over the course of the study. These adverse events will be self-reported using a questionnaire and will be analyzed using frequencies, means, and measures of variability.
Time Frame
12 week measurement point
Title
Self-report questionnaire on the feasibility and usability of exercising using the 9 zest app
Description
A 5 point Likert style, self-report questionnaire with 6 items taken from the Intrinsic Motivation Inventory will be used to examine ease of use, design, user friendliness of exercising while using the 9zest app. Each of the 6 items will be reported separately. Scores range from 1 to 5 for each item.
Time Frame
12 week measurement point
Secondary Outcome Measure Information:
Title
The change in the number of times a participant can go from sitting to standing in 30 seconds
Description
The 30 second Sit-To-Stand test will be used to determine a signal of efficacy for functional lower extremity strength.
Time Frame
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Title
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.
Description
The Timed Up and Go Test will be used for a signal of efficacy regarding dynamic gait performance.
Time Frame
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Title
The change in score on a self-report questionnaire of quality of life regarding mobility
Description
The Parkinson's Disease Questionnaire-39 mobility subscale has 10 disease-specific mobility-related questions and will be used to determine a signal of efficacy related to disease-specific mobility. Each of the 10 items has a 5 item Likert response with scores ranging from 0 to 4. The scores of all 10 items will be added up and divided by the total possible points (40 points); thus, this outcome measurement will be reported as a percent of the total possible points with a lower score being suggestive of higher mobility-related quality of life.
Time Frame
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Majmundar, MS
Phone
650-8678-729
Email
sam@9zest.com
First Name & Middle Initial & Last Name or Official Title & Degree
Merrill Landers, DPT, PhD
Phone
7022413663
Email
merrill.landers@unlv.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merrill Landers, DPT, PhD
Organizational Affiliation
UNLV, Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merrill Landers
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merrill Landers
Phone
702-895-1377

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33016887
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.
Results Reference
derived

Learn more about this trial

A Mobile Application for Telerehabilitation in Parkinson's Disease

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