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

NCT06896123 | Completed

• 1 other identifier: DWpsVMF
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

PD; Dance Well; Rehabilitation Therapy

Outcome Measures

Primary Outcomes (1)

• UPDRS III

  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.

  Form the enrollment to the end of treatment at 4 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

DanceWell Group

EXPERIMENTAL

12 PD patients underwent 4-week Dance Well Program

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

Conventional Therapy Group

ACTIVE COMPARATOR

12 PD patients underwent 4-week Conventional Therapy Program

Behavioral: Conventional motor therapy group

Interventions

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

DanceWell Group

Conventional motor therapy group BEHAVIORAL

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

Conventional Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Casa di Cura Villa Margherita Fresco: lead

Study Sites (1)

Fresco Parkinson Center - Villa Margherita (KOS group)

Arcugnago, VI, 36057, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of KOS Medical Group

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 26, 2025
• Study Start: January 7, 2022
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)