NCT07382674

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
21mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Parkinson Disease

Keywords

ExerciseRoboticsParkinson's diseaseCaregiversArtificial IntelligenceStrength

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Baseline, after 3 weeks

Secondary Outcomes (4)

  • Feasibility (Session Adherence)

    Throughout 3-week intervention

  • Retention

    Throughout 3-week intervention

  • Safety (Adverse Events)

    Throughout 3-week intervention

  • Acceptability and Tolerability

    Throughout 3-week intervention

Study Arms (2)

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.

Other: 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.

Other: ZEST-E Robot-Assisted Exercise Program

Interventions

ZEST-E Robot-Assisted Exercise ProgramOTHER

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

In-Person Monitored ZEST-E ExerciseRemotely Monitored ZEST-E Exercise

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults with mild to moderate PD.

You may not qualify if:

  • 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);
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University, 57 Executive Park S NE, Ste 200

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Madeleine Hackney, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Hackney, PhD

CONTACT

314-412-4852mehackn@emory.edu

Hannah Kim

CONTACT

hannah.kim3@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)