Clinical trial NCT06896123: Dance Well Therapy: a Study for Evaluating Efficacy, Safety, and Feasibility
Official title: Studio Sulla Fattibilità e Sul Potenziale Riabilitativo Dell'Esperienza Artistica di Dance Well Nei Pazienti Affetti da Malattia di Parkinson
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: PD
Dance Well
Rehabilitation Therapy
Lead sponsor: Casa di Cura Villa Margherita Fresco
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: UPDRS III
timeFrame: Form the enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: 6-Minute Walk Test (6MWT)
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: Timed Up and Go (TUG) Test
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: Corsi Supra-Span Block Tapping Test
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: Trail Making Test (TMT) A and B-A
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: State-Trait Anxiety Inventory (STAI-I) part I
timeFrame: Form the enrollment to the end of treatment at 4 weeks
measure: Apathy Evaluation Scale (AES)
timeFrame: Form the enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Arcugnago
country: Italy
facility: Fresco Parkinson Center - Villa Margherita (KOS group)
state: VI
Study officials:
References: