Effectiveness of Tango Therapy and Physical Reconditioning in Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Examination Score
研究概览
简要总结
The purpose of this clinical research is to evaluate the effectiveness of a structured Tango-based (Riabilitango®) therapy compared to a conventional Motor Reconditioning program and a Control group in individuals diagnosed with Parkinson's Disease. The study assesses changes in motor performance, balance, gait kinematics, functional strenght, and health-related quality of life over a 3-month intervention period and a 3-month post-intervention follow-up.
详细描述
Parkinson's disease is characterized by motor deficits affecting gait, postural control, and dynamic balance. This study compares two exercise-based rehabilitation approaches against a control group:
Riabilitango® (Tango Therapy): Supervised group sessions (2 times/week, 60 minutes/session for 3 months) focusing on balance, trunk mobility, rhythm-synchronised walking, and adapted Argentine tango figures.
Motor Reconditioning: Supervised small-group sessions (2 times/week, 60 minutes/session for 3 months) including cycling warm-up, progressive treadmill walking (60-70% max heart rate), upper/lower-limb functional training, and stretching exercises.
Control Group: Follows usual care without participating in the structured rehabilitation interventions during the study period.
Comprehensive clinical, functional, and biomechanical evaluations are conducted at baseline, monthly during the 3-month intervention period, and at a 3-month post-intervention follow-up (6 months total observation period).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of idiopathic Parkinson's Disease.
- •Mild to moderate disease severity (Hoehn and Yahr stage I-III).
- •Ability to walk independently (with or without assistive devices).
- •Stable antiparkinsonian pharmacological treatment for at least 4 weeks prior to enrollment.
- •Ability to understand study procedures and willingness to sign the Informed Consent document.
排除标准
- •Severe cognitive impairment or dementia preventing comprehension of instructions or active participation.
- •Severe cardiovascular, respiratory, orthopedic, or other neurological conditions that impair safe exercise participation or gait evaluation.
- •Surgical interventions that directly affect mobility or dynamic balance (e.g., Deep Brain Stimulation or recent major orthopedic surgery).
- •Concurrent participation in other physical rehabilitation programs or clinical trials during the study period.
结局指标
主要结局
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Examination Score
时间窗: Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6)
The UPDRS Part III evaluates motor function in individuals with Parkinson's disease, including speech, facial expression, tremor, rigidity, finger taps, hand movements, gait, posture, and bradykinesia. Scores range from 0 to 56, with higher scores indicating greater motor impairment.
次要结局
- Timed Up and Go (TUG) Test Time(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Six-Minute Walk Test (6MWT) Distance(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Handgrip Strength(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Sit-and-Reach Test Distance(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Back Scratch Test Distance(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Gait Speed(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Step Length(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Vertical Displacement During Gait(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Postural Alignment During Gait(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Postural Sway Area(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Center of Pressure Displacement Length(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Pelvic Proprioceptive Balance(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Supine Postural Asymmetries(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- 39-Item Parkinson's Disease Questionnaire (PDQ-39) Summary Index(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- 36-Item Short Form Health Survey (SF-36) Total Score(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
- Zung Self-Rating Depression Scale Score(Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6))
研究者
Anna Antonia Valenzano
Associate Professor
University of Foggia