Zesty Exercise System for Therapeutic Engagement

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство ZEST-E Robot-Assisted Exercise Program
  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 reque

Первичные конечные точки

• Standing Forward Reach (SFR) Test [Срок оценки: Baseline, after 3 weeks]
• 30-Second Chair Stand Test [Срок оценки: Baseline, after 3 weeks]

Вторичные конечные точки (4)

• Feasibility (Session Adherence) [Срок оценки: Throughout 3-week intervention]
• Retention [Срок оценки: Throughout 3-week intervention]
• Safety (Adverse Events) [Срок оценки: Throughout 3-week intervention]
• Acceptability and Tolerability [Срок оценки: Throughout 3-week intervention]

Критерии участия

Критерии включения

-Older adults with mild to moderate PD.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Emory University, 57 Executive Park S NE, Ste 200 — Atlanta

Идентификаторы

NCT: NCT07382674 · 2024P006965

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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