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临床试验/NCT06896123
NCT06896123已完成不适用

Studio Sulla Fattibilità e Sul Potenziale Riabilitativo Dell'Esperienza Artistica di Dance Well Nei Pazienti Affetti da Malattia di Parkinson

Casa di Cura Villa Margherita Fresco1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
UPDRS III

研究概览

简要总结

A new and in-teresting complementary approach for rehabilitation of parkinsonian patients is represented by "Dance Well", which is an artistic, multisensory dance intervention based on art and music. This study aims to evaluate the efficacy, feasibility, and safety of a 4-week Dance Well (DW) program in PD patients in early-medium disease stages.

详细描述

Background/Objectives: Parkinson's disease (PD) is a complex neurodegenerative disorder re-sponsible for both motor and non-motor disturbances impairing the motor behaviour. This com-plexity needs for integrated, multidisciplinary and comprehensive models of care. A new and in-teresting complementary approach is represented by "Dance Well," i.e., an artistic, multisensory dance intervention based on art and music. This pilot study aims to evaluate the efficacy, feasibility, and safety of a 4-week Dance Well (DW) program in PD patients in early-medium disease stages. Methods: Twenty-four PD patients (H&Y ≤ 3; MoCA score ≥ 13.8) were enrolled and randomly allocated into two groups, both with a twice per week frequency and lasting 4 weeks: one group underwent the DW program, while the other underwent conventional physiotherapy (CPT). De-mographic, biometric, and clinical data were collected. To study the treatment effect, motor (Unified PD Rating Scale-III, Timed-up and Go Test, Berg Balance Scale, 6-Minute Walk Test, and Falls Efficacy Scale), cognitive (Corsi Supra Span Test, Trial Making Test A and B-A), and affective (Beck Depression Inventory, State-Trait Anxiety Inventory, Apathy Evaluation Scale) outcome measures were as-sessed, before and after rehabilitation program. To study the treatment compliance and safety, number of dropouts and any adverse events (such as injuries and falls) were recorded.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •diagnosis of PD according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria; rate score 0-3 on the modified Hoehn & Yahr (H&Y) scale.

排除标准

  • •other neurological or psychiatric diseases other than PD;
  • •serious visual and/or auditory deficits;
  • •orthopedic-muscular and or co-morbid medical conditions precluding partici-pation in dance;
  • •cognitive decline (MoCA score < 13,8)

研究组 & 干预措施

DanceWell Group

Experimental

12 PD patients underwent 4-week Dance Well Program

干预措施: Dance Well: an artistic, multisensory dance intervention based on art and music (Behavioral)

Conventional Therapy Group

Active Comparator

12 PD patients underwent 4-week Conventional Therapy Program

干预措施: Conventional motor therapy group (Behavioral)

结局指标

主要结局

UPDRS III

时间窗: Form the enrollment to the end of treatment at 4 weeks

UPDRS III (Unified Parkinson's Disease Rating Scale, Part III) is a clinical tool used to assess motor function in Parkinson's disease patients. It evaluates symptoms such as tremors, rigidity, bradykinesia, postural stability, gait, and rapid alternating movements. Each item is scored from 0 (no impairment) to 4 (severe impairment), with the total score indicating the overall severity of motor symptoms.

次要结局

  • Berg Balance Scale (BBS)(Form the enrollment to the end of treatment at 4 weeks)
  • 6-Minute Walk Test (6MWT)(Form the enrollment to the end of treatment at 4 weeks)
  • Timed Up and Go (TUG) Test(Form the enrollment to the end of treatment at 4 weeks)
  • Corsi Supra-Span Block Tapping Test(Form the enrollment to the end of treatment at 4 weeks)
  • Trail Making Test (TMT) A and B-A(Form the enrollment to the end of treatment at 4 weeks)
  • Beck Depression Inventory (BDI)(Form the enrollment to the end of treatment at 4 weeks)
  • State-Trait Anxiety Inventory (STAI-I) part I(Form the enrollment to the end of treatment at 4 weeks)
  • Apathy Evaluation Scale (AES)(Form the enrollment to the end of treatment at 4 weeks)

研究者

发起方
Casa di Cura Villa Margherita Fresco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giampietro Rupolo

President of KOS Medical Group

Casa di Cura Villa Margherita Fresco

研究点 (1)

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