Community-based Participatory Evaluation Studies on a Partnered Dance Program for Adults With Neurodegenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Participants' Satisfaction of the intervention (Acceptability)
研究概览
简要总结
This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's disease or Mild Cognitive Impairment, and younger individuals before and after the Adaptango performance process.
详细描述
This is a pilot study designed to assess the impact of the mediator/instructor role between dyads of older and younger adults as they engage in art and dance activities that address challenging topics.
The study aims to evaluate the effects of the Adaptango Performance Process (APP) on creativity, justice, and quality of life among persons with Parkinson's disease (PWP), people living with dementia (PLWD), and young adult participants. Validated measures of creativity, justice, and quality of life will be administered before and after the intervention.
The findings from this pilot phase will be used to inform the design and power calculations of future larger clinical trials intended to more definitively evaluate the effects of the APP program on creativity, engagement with challenging topics of societal importance, and psychosocial health across generations.
Findings from the arts-based method evaluation will also be considered when interpreting and reporting study results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals (PWP, younger adults, PLwD) from the greater Atlanta area. Those in the PWP group must be diagnosed by a neurologist specialized in Parkinson's disease.
- •Score of at least 18 on the Montreal Cognitive Assessment (MoCA). Those who are in the PLwD group must score between 18 and 25 on the MoCA.
排除标准
- •Acute medical illness requiring hospitalization
- •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)
- •Taking medications that could adversely affect cognition, e.g., antipsychotics, opioids, stimulants, chemotherapy, neurologic prescriptions to treat Multiple sclerosis. When applicable, enrollment will be delayed until dosages are stable on, e.g., Aricept, Namenda, anticholinesterase inhibitors, for at least 3 months
- •Psychotic disorders
- •Confounding neurologic conditions [e.g., active central nervous system (CNS) 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 Disorder, and Generalized Anxiety Disorders within six months of evaluation
- •Unable to provide informed consent
- •Cognitively impaired individuals or individuals with impaired decision-making, individuals who are not yet adults, pregnant women, prisoners
- •Not able to clearly understand English
研究组 & 干预措施
Healthy adults over 18 and less than 31 years
Healthy adults over 18 and less than 31 years
干预措施: Adaptango Performance Process (APP) program (Other)
Adults with Parkinson's disease (PD) age 50 years and over
Adults with Parkinson's disease aged 50 years and over
干预措施: Adaptango Performance Process (APP) program (Other)
Adults with mild cognitive impairment (MCI) age 50 years and over
Adults with MCI aged 50 years and over
干预措施: Adaptango Performance Process (APP) program (Other)
结局指标
主要结局
Participants' Satisfaction of the intervention (Acceptability)
时间窗: Post-intervention at 8 months
Satisfaction will be assessed post-intervention only with an Exit Questionnaire balanced for gender and race. Participants will rate (extremely easy/very easy) and their overall satisfaction with the intervention. A higher score indicates better satisfaction.
Alternate Uses Task (AUT)
时间窗: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Alternate Uses Task (AUT) will be used to assess the patient's creativity by asking them to come up with as many alternate uses for an everyday object as possible in two minutes. Results are measured across four subscales: fluency- the number of alternative uses thought of originality - how unusual the uses given are; flexibility - the range of ideas in different categories; and elaboration-the level of detail given to an idea. Higher values in each subscale indicate higher levels of creativity.
次要结局
- Parkinson's Disease Questionnaire Summary Index (PDQ-39 SI)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- The Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- 30-second chair stand test(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- 360 turn test (Time)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- 360 turn test (steps)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- Static Postural Balance Assessment via Tandem Stance Test(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- Mini-Balance Evaluation Systems Test (Mini-BESTest)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- The Dynamic Gait Index (DGI)(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- Gait speed test(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- Four-square step test(Baseline, 3 months (during intervention), and 8 months (post-intervention))
- The Multidimensional Scale of Perceived Social Support (MSPSS) Score(Baseline, 3 months (during APP ), and 8 months (after the APP program))
- The Short Form 12-Quality of Life (SF12)(Baseline, 3 months (during APP ), and 8 months (after the APP program))
- The Impact on Participation and Autonomy Questionnaire (IPAQ).(Baseline, 3 months (during intervention), and 8 months (post-intervention))
研究者
Madeleine Eve Hackney
Associate Professor
Emory University