Zesty Exercise System for Therapeutic Engagement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Standing Forward Reach (SFR) Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults with mild to moderate PD.
排除标准
- •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
研究组 & 干预措施
In-Person Monitored ZEST-E Exercise
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.
干预措施: ZEST-E Robot-Assisted Exercise Program (Device)
Remotely Monitored ZEST-E Exercise
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.
干预措施: ZEST-E Robot-Assisted Exercise Program (Device)
结局指标
主要结局
Standing Forward Reach (SFR) Test
时间窗: 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
时间窗: Baseline, after 3 weeks
Number of full sit-to-stand repetitions completed in 30 seconds. Higher counts indicate greater lower-body strength
次要结局
- 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)
研究者
Madeleine Eve Hackney
Associate Professor
Emory University