Parkinson DiseaseZEST-ENCT07382674
Zesty Exercise System for Therapeutic Engagement
A study testing ZEST-E Robot-Assisted Exercise Program in people with Parkinson Disease, run by Emory University at 1 site in United States.
Trial summary
This study will evaluate exercise delivered through the Zesty Exercise System for Therapeutic Engagement (ZEST-E) for people with Parkinson's disease when sessions are monitored either in person or remotely. Participants will complete robot-guided exercise three times per week for three weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ZEST-E Robot-Assisted Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Older adults with mild to moderate PD.
Who cannot join
- Acute medical illness requiring hospitalization;
- Under 40 years old;
- Uncontrolled congestive heart failure;
- History of stroke in the past three years;
- Inability to perform study procedures;
- Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity);
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- On medications that could adversely affect cognition, e.g.: antipsychotics, opioids, stimulants, chemotherapy;
- Psychotic disorders;
- Confounding neurologic conditions (e.g., active central nervous system opportunistic infections, seizure disorders, head injury with loss of consciousness >30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae);
- Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation;
- Hohn \& Yahr > 3
- MoCA <17
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Kim contact
United States1 site, 1 recruiting
- Recruiting
Emory University, 57 Executive Park S NE, Ste 200
Atlanta, Georgia, 30329
Madeleine Hackney, PhD, mehackn@emory.edu
About this study
This study will evaluate exercise delivered through the Zesty Exercise System for Therapeutic Engagement (ZEST-E) for people with Parkinson's disease when sessions are monitored either in person or remotely. Participants will complete robot-guided exercise three times per week for three weeks. The study will assess feasibility, retention, safety, acceptability, and tolerability of remotely monitored ZEST-E and will measure changes in functional performance using the Standing Forward Reach test and the 30-Second Chair Stand test. These outcomes reflect range of motion and lower-body strength targeted by the exercise program.
Read the detailed description
Parkinson's disease is associated with reduced range of motion, impaired postural control, and decreased lower-body strength, which contribute to mobility limitations and reduced functional independence. Exercise is an essential component of symptom management and has been shown to improve strength, balance, and overall physical function. Many individuals with Parkinson's disease, however, face barriers to accessing supervised exercise, including transportation challenges, limited availability of trained providers, and difficulty maintaining consistent participation. Remote delivery of structured exercise may increase accessibility, but its feasibility and safety for use with robotic exercise systems have not been fully evaluated.
The Zesty Exercise System for Therapeutic Engagement (ZEST-E) is a robotic platform designed to guide users through structured physical activity tasks that target range of motion and lower-body strength. The system provides interactive movement prompts and real-time feedback through a robotic interface. Previous work has shown that ZEST-E can be used safely and effectively in supervised settings. The current study will evaluate the use of ZEST-E when exercise sessions are monitored either in person or remotely.
Participants will complete exercise sessions three times per week for three weeks. Each session will include robot-guided movements such as forward reaching, leaning, and repeated sit-to-stand transitions. Remote monitoring will be conducted through real-time audiovisual supervision, while in-person monitoring will occur on-site. Caregivers of participants can co-enroll and will receive fall prevention training, which they will practice during the exercise sessions. Throughout the study, information will be collected on session completion, participant experience, caregiver stress, and any safety concerns.
The study will also measure changes in functional performance. The Standing Forward Reach test will be used to assess range of motion, and the 30-Second Chair Stand test will be used to assess lower-body strength. These outcomes were selected because they reflect motor abilities targeted by the ZEST-E exercise protocol. The results will provide information about the feasibility, acceptability, and safety of remotely monitored robotic exercise and will support planning for future research using this technology.
- Conditions
- Parkinson Disease
- Being tested
- ZEST-E Robot-Assisted Exercise Program
- Keywords
- Exercise, Robotics, Parkinson's disease, Caregivers, Artificial Intelligence, Strength
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEST-E Robot-Assisted Exercise ProgramDevice
Participants complete robot-guided exercises using the ZEST-E system. Sessions include reaching, stretching, and dual-task movements for upper and lower limbs. Before each exercise, participants view a video demonstration or receive instruction from staff. ZEST-E presents targets to tap with hands, feet, or knees and uses calibration and practice trials to set positions. The robot operates with force-limited controls, back-drivable joints, and an emergency run-stop button. Participants may request to stop the robot at any time. All participants begin with seated exercises in week 1 and may progress to standing exercises in weeks 2-3 after completing a safety tutorial. Safety supports such as mats, chairs, and gait belts are used during standing tasks.
Training will consist of 1-hour bouts, 3 times/week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| In-Person Monitored ZEST-E Exercise | Experimental | Participants complete ZEST-E exercise sessions with a researcher or physical therapist present in the same room to provide safety oversight. All participants begin with seated exercises in week 1 and may progress to standing exercises in weeks 2 and 3 after completing a safety tutorial and demonstrating understanding of standing-exercise precautions. The researcher monitors the robot, provides instructions, and may stop the robot at any time using the run-stop button if needed. Receives: Device: ZEST-E Robot-Assisted Exercise Program |
| Remotely Monitored ZEST-E Exercise | Experimental | Participants complete ZEST-E exercise sessions while the researcher or physical therapist monitors the session remotely via camera from outside the room. A trained caregiver is present in the room to provide safety oversight and to activate the robot's run-stop button if needed. Participants follow the same progression from seated to standing exercises as in the in-person arm, contingent on completion of the safety tutorial and demonstration of safe technique. Receives: Device: ZEST-E Robot-Assisted Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing Forward Reach (SFR) Test
This test measures forward reach distance while standing to assess range of motion and postural control. Greater reach distance indicates improved mobility.
Measured: Baseline, after 3 weeks
30-Second Chair Stand Test
Number of full sit-to-stand repetitions completed in 30 seconds. Higher counts indicate greater lower-body strength
Measured: Baseline, after 3 weeks
Secondary outcomes (4)
Feasibility (Session Adherence)
Proportion of scheduled ZEST-E sessions completed.
Measured: Throughout 3-week intervention
Retention
Percentage of participants who complete all study assessments.
Measured: Throughout 3-week intervention
Safety (Adverse Events)
Number and type of adverse events reported during ZEST-E sessions.
Measured: Throughout 3-week intervention
Acceptability and Tolerability
Participant ratings of comfort, ease of use, and overall experience using standardized questionnaires.
Measured: Throughout 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start16 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Responsible party
- Principal investigator, Madeleine Eve Hackney, Emory University
- Investigators
- Madeleine Hackney, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382674
- Sponsor's protocol ID
- 2024P006965
- Acronym
- ZEST-E
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zesty Exercise System for Therapeutic Engagement
- ClinicalTrials.gov ID
- NCT07382674
- Acronym / sponsor ID
- ZEST-E / 2024P006965
- Conditions
- Parkinson Disease
- Keywords
- Exercise, Robotics, Parkinson's disease, Caregivers, Artificial Intelligence, Strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Feb 2026 (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.
This study will evaluate exercise delivered through the Zesty Exercise System for Therapeutic Engagement (ZEST-E) for people with Parkinson's disease when sessions are monitored either in person or remotely. Participants will complete robot-guided exercise three times per week for three weeks. The study will assess feasibility, retention, safety, acceptability, and tolerability of remotely monitored ZEST-E and will measure changes in functional performance using the Standing Forward Reach test and the 30-Second Chair Stand test. These outcomes reflect range of motion and lower-body strength targeted by the exercise program.
Detailed description
Parkinson's disease is associated with reduced range of motion, impaired postural control, and decreased lower-body strength, which contribute to mobility limitations and reduced functional independence. Exercise is an essential component of symptom management and has been shown to improve strength, balance, and overall physical function. Many individuals with Parkinson's disease, however, face barriers to accessing supervised exercise, including transportation challenges, limited availability of trained providers, and difficulty maintaining consistent participation. Remote delivery of structured exercise may increase accessibility, but its feasibility and safety for use with robotic exercise systems have not been fully evaluated.
The Zesty Exercise System for Therapeutic Engagement (ZEST-E) is a robotic platform designed to guide users through structured physical activity tasks that target range of motion and lower-body strength. The system provides interactive movement prompts and real-time feedback through a robotic interface. Previous work has shown that ZEST-E can be used safely and effectively in supervised settings. The current study will evaluate the use of ZEST-E when exercise sessions are monitored either in person or remotely.
Participants will complete exercise sessions three times per week for three weeks. Each session will include robot-guided movements such as forward reaching, leaning, and repeated sit-to-stand transitions. Remote monitoring will be conducted through real-time audiovisual supervision, while in-person monitoring will occur on-site. Caregivers of participants can co-enroll and will receive fall prevention training, which they will practice during the exercise sessions. Throughout the study, information will be collected on session completion, participant experience, caregiver stress, and any safety concerns.
The study will also measure changes in functional performance. The Standing Forward Reach test will be used to assess range of motion, and the 30-Second Chair Stand test will be used to assess lower-body strength. These outcomes were selected because they reflect motor abilities targeted by the ZEST-E exercise protocol. The results will provide information about the feasibility, acceptability, and safety of remotely monitored robotic exercise and will support planning for future research using this technology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Monitored ZEST-E Exercise | Experimental | Device: ZEST-E Robot-Assisted Exercise ProgramParticipants complete ZEST-E exercise sessions with a researcher or physical therapist present in the same room to provide safety oversight. All participants begin with seated exercises in week 1 and may progress to standing exercises in weeks 2 and 3 after completing a safety tutorial and demonstrating understanding of standing-exercise precautions. The researcher monitors the robot, provides instructions, and may stop the robot at any time using the run-stop button if needed. |
| Remotely Monitored ZEST-E Exercise | Experimental | Device: ZEST-E Robot-Assisted Exercise ProgramParticipants complete ZEST-E exercise sessions while the researcher or physical therapist monitors the session remotely via camera from outside the room. A trained caregiver is present in the room to provide safety oversight and to activate the robot's run-stop button if needed. Participants follow the same progression from seated to standing exercises as in the in-person arm, contingent on completion of the safety tutorial and demonstration of safe technique. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Older adults with mild to moderate PD.
Key exclusion criteria (12 listed)
- Acute medical illness requiring hospitalization;
- Under 40 years old;
- Uncontrolled congestive heart failure;
- History of stroke in the past three years;
- Inability to perform study procedures;
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 |
|---|---|---|
| ZEST-E Robot-Assisted Exercise ProgramParticipants complete robot-guided exercises using the ZEST-E system. Sessions include reaching, stretching, and dual-task movements for upper and lower limbs. Before each exercise, participants view a video demonstration or receive instruction from staff. ZEST-E presents targets to tap with hands, feet, or knees and uses calibration and practice trials to set positions. The robot operates with force-limited controls, back-drivable joints, and an emergency run-stop button. Participants may request to stop the robot at any time. All participants begin with seated exercises in week 1 and may progress to standing exercises in weeks 2-3 after completing a safety tutorial. Safety supports such as mats, chairs, and gait belts are used during standing tasks. Training will consist of 1-hour bouts, 3 times/week for 3 weeks | Device | In-Person Monitored ZEST-E Exercise, Remotely Monitored ZEST-E Exercise |
Primary outcome
Standing Forward Reach (SFR) Test
Time frame: Baseline, after 3 weeks
This test measures forward reach distance while standing to assess range of motion and postural control. Greater reach distance indicates improved mobility.
30-Second Chair Stand Test
Time frame: Baseline, after 3 weeks
Number of full sit-to-stand repetitions completed in 30 seconds. Higher counts indicate greater lower-body strength
4 secondary outcomes
Feasibility (Session Adherence)
Time frame: Throughout 3-week intervention
Retention
Time frame: Throughout 3-week intervention
Safety (Adverse Events)
Time frame: Throughout 3-week intervention
Acceptability and Tolerability
Time frame: Throughout 3-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
Hannah Kim contact
Madeleine Hackney, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZEST-E Robot-Assisted Exercise Program in people with Parkinson Disease, run by Emory University 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 1 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine Hackney, PhD (314-412-4852, mehackn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standing Forward Reach (SFR) Test (time frame: Baseline, after 3 weeks). 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?
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 26 May 2026.