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NCT Number: NCT07382674

Zesty Exercise System for Therapeutic Engagement

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, 57 Executive Park S NE, Ste 200

Atlanta, Georgia, 30329, United States

Location status: Recruiting

Location contact

Madeleine Hackney, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Older adults with mild to moderate PD.

Exclusion criteria

  • 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

Treatment and study plan

ZEST-E Robot-Assisted Exercise Program

Device

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Feasibility (Session Adherence)

    Time frame: Throughout 3-week intervention

    Proportion of scheduled ZEST-E sessions completed.

  2. Retention

    Time frame: Throughout 3-week intervention

    Percentage of participants who complete all study assessments.

  3. Safety (Adverse Events)

    Time frame: Throughout 3-week intervention

    Number and type of adverse events reported during ZEST-E sessions.

  4. Acceptability and Tolerability

    Time frame: Throughout 3-week intervention

    Participant ratings of comfort, ease of use, and overall experience using standardized questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Kim

CONTACT

[email protected]

Madeleine Hackney, PhD

CONTACT

[email protected]

314-412-4852

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Clinical & Translational Science Alliance

Registry information

Acronym: ZEST-E

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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