A Mobile Application for Telerehabilitation in Parkinson's Disease
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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Feb 2018
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2018
CompletedStudy Start
First participant enrolled
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 9, 2018
March 1, 2018
9 months
February 24, 2018
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
12 week measurement point
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.
12 week measurement point
Secondary Outcomes (3)
The change in the number of times a participant can go from sitting to standing in 30 seconds
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
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.
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
The change in score on a self-report questionnaire of quality of life regarding mobility
Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Study Arms (1)
9zest app facilitated exercise
EXPERIMENTALApp 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 9zest. Inc.lead
- University of Nevada, Las Vegascollaborator
- Boston Universitycollaborator
Study Sites (1)
Merrill Landers
Las Vegas, Nevada, 89154, United States
Related Publications (1)
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.
PMID: 33016887DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merrill Landers, DPT, PhD
UNLV, Las Vegas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2018
First Posted
March 9, 2018
Study Start
February 28, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 9, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share