Parkinson DiseaseNCT03459586
A Mobile Application for Telerehabilitation in Parkinson's Disease
A study testing 9zest app facilitated exercise in people with Parkinson Disease, run by 9zest. Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 9zest app facilitated exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Merrill Landers
Las Vegas, Nevada, 89154
Merrill Landers, 702-895-1377
About this study
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
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.
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- 9zest app facilitated exercise
- Keywords
- Parkinson
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9zest app facilitated exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 9zest app facilitated exercise | Experimental | 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. Receives: Other: 9zest app facilitated exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The 30 second Sit-To-Stand test will be used to determine a signal of efficacy for functional lower extremity strength.
Measured: 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.
The Timed Up and Go Test will be used for a signal of efficacy regarding dynamic gait performance.
Measured: 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
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.
Measured: Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start28 Feb 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 9zest. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nevada, Las Vegas, Boston University
- Responsible party
- Sponsor
- Investigators
- Merrill Landers, DPT, PhD, Principal investigator, UNLV, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459586
- Sponsor's protocol ID
- 9zest parkinson study
- Status last verified
- Mar 2018
- First submitted
- 24 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33016887
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03459586
- Acronym / sponsor ID
- 9zest parkinson study
- Conditions
- Parkinson Disease
- Keywords
- Parkinson
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- 9zest. Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nevada, Las Vegas, Boston University
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 9zest app facilitated exercise | Experimental | Other: 9zest app facilitated exerciseApp 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 may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9zest app facilitated exerciseThe 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 | Other | 9zest app facilitated exercise |
Primary outcome
Incidence of adverse events and falls during exercise using the 9 zest app
Time frame: 12 week measurement point
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
Time frame: 12 week measurement point
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.
3 secondary outcomes
The change in the number of times a participant can go from sitting to standing in 30 seconds
Time frame: 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.
Time frame: 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
Time frame: Change in score from pretest to 3 posttests (4 week, 8 week, and 12 week measurement points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 33016887Landers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merrill Landers, DPT, PhD principal investigator
UNLV, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9zest app facilitated exercise in people with Parkinson Disease, run by 9zest. Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Majmundar, MS (650-8678-729, sam@9zest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and falls during exercise using the 9 zest app (time frame: 12 week measurement point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.