Dance Well Therapy: a Study for Evaluating Efficacy, Safety, and Feasibility

NCT ID: NCT06896123

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2022-09-30

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DanceWell Group

12 PD patients underwent 4-week Dance Well Program

Group Type: EXPERIMENTAL

Dance Well: an artistic, multisensory dance intervention based on art and music

Intervention Type: BEHAVIORAL

DW is specifically designed for people with early to mild severe PD and aims to de-liver multiple stimuli, including rhythmical auditory cues, proprioceptive and sensorimo-tor stimulation, balance training, and aerobic exercise, using carefully selected music to cue movement and promote relaxation. The components of DW are relatively simple and easy to be learned and performed for people with compromised mobility. The intervention is also enjoyable and engaging, as reported for other genres of dance

Conventional Therapy Group

12 PD patients underwent 4-week Conventional Therapy Program

Group Type: ACTIVE_COMPARATOR

Conventional motor therapy group

Intervention Type: BEHAVIORAL

Conventional Motor Therapy consisted on 60-minute conventional physiotherapy, twice a week, for four weeks

Interventions

Dance Well: an artistic, multisensory dance intervention based on art and music

DW is specifically designed for people with early to mild severe PD and aims to de-liver multiple stimuli, including rhythmical auditory cues, proprioceptive and sensorimo-tor stimulation, balance training, and aerobic exercise, using carefully selected music to cue movement and promote relaxation. The components of DW are relatively simple and easy to be learned and performed for people with compromised mobility. The intervention is also enjoyable and engaging, as reported for other genres of dance

Intervention Type: BEHAVIORAL

Conventional motor therapy group

Conventional Motor Therapy consisted on 60-minute conventional physiotherapy, twice a week, for four weeks

Intervention Type: BEHAVIORAL

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Casa di Cura Villa Margherita Fresco

OTHER

Sponsor Role: lead

Responsible Party

Giampietro Rupolo

President of KOS Medical Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fresco Parkinson Center - Villa Margherita (KOS group)

Arcugnago, VI, Italy

Countries

Italy

Other Identifiers

DWpsVMF

Identifier Type: -

Identifier Source: org_study_id