Online Dance Versus Online Therapeutic Exercise on Quality of Life - A Protocol for a Randomized Controlled Trial Investigating Social Telerehabilitation Efficacy in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assessment of Well-being
研究概览
简要总结
This is a randomized clinical trial in an online format, which will only include people with PD randomly divided into two groups:
Group 1 - Social Telerehabilitation with Dance and Music Group 2 - Social Telerehabilitation with Multimodal Therapeutic Exercise and Music
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of idiopathic PD according to the clinical criteria of the London Brain Bank Criteria (2006);
- •Age between 40-90 years;
- •A minimum score of 18 in the Montreal Cognitive Assessment;
- •Drug therapy/exercise stable for at least four weeks before the study starts;
- •Agreement to participate in the study according to the Informed Consent Form.
排除标准
- •Auditory and/or visual disturbances that compromise understanding simple commands;
- •Access to the internet and a device to access online classes;
- •A house member and/or caregiver at home for supervision during the entire experiment, including evaluations and interventions. For patients scoring less than 2.5 points on the modified Hoehn and Yahr Scale (indicating mild disease impairment, independence in daily living activities, and no risk of falls), the requirement for household member supervision may be waived.
结局指标
主要结局
Assessment of Well-being
时间窗: Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Well-being measured by the scale Positive and Negative Affect Scale (PANAS). scores range from 10 - 50, a higher score indicates more of a positive affect.
Assessment of Quality of life
时间窗: Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Quality of life measured by Parkinson's Disease Questionnaire (PDQ-39). Scores range from 0-100 (100 = maximum level of problems).
次要结局
- Assessment of Attention and Memory Recognition(Change from Pre to Post treatment (12 weeks))
- Assessment of Functional lower extremity strength(Change from Pre to Post treatment (12 weeks))
- Assessment of Symptoms of Anxiety(Change from Pre to Post treatment (12 weeks))
- Feasibility (self-perceptions)(Change from Pre to Post treatment (12 weeks))
- Assessment of Motor symptoms severity(Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending))
研究者
Aline de Souza Pagnussat
Principal Investigator
Federal University of Health Science of Porto Alegre