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

March 25, 2025 updated by: Giampietro Rupolo, Casa di Cura Villa Margherita Fresco

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VI
      • Arcugnago, VI, Italy, 36057
        • Fresco Parkinson Center - Villa Margherita (KOS group)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DanceWell Group
12 PD patients underwent 4-week Dance Well Program
Behavioral: 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
Active Comparator: Conventional Therapy Group
12 PD patients underwent 4-week Conventional Therapy Program
Behavioral: Conventional motor therapy group
Conventional Motor Therapy consisted on 60-minute conventional physiotherapy, twice a week, for four weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
UPDRS III
Time Frame: 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.
Form the enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Form the enrollment to the end of treatment at 4 weeks
The Berg Balance Scale (BBS) is a widely used tool designed to assess static balance and fall risk in adults. Here are the key points. The scale must be administered by a trained physical therapist, and it consists of 14 tasks, each scored on a 5-point scale (0-4), with 0 indicating the lowest level of function and 4 the highest. Tasks includes activities like sitting to standing, standing unsupported, reaching forward, and turning 360 degrees. It typically takes 15-20 minutes to administer.
Form the enrollment to the end of treatment at 4 weeks
6-Minute Walk Test (6MWT)
Time Frame: Form the enrollment to the end of treatment at 4 weeks
The 6-Minute Walk Test (6MWT) is a simple and effective tool used to assess aerobic capacity and endurance, measuring the distance as far as possible an individual can walk in six minutes on a flat, straight surface. The outcome is the total distance walked in meters within the six-minute period. Participants are encouraged to walk back and forth along a marked walkway, with standardized encouragement provided at specific intervals. This test is widely used in clinical and research settings to evaluate walk and to monitor changes over time.
Form the enrollment to the end of treatment at 4 weeks
Timed Up and Go (TUG) Test
Time Frame: Form the enrollment to the end of treatment at 4 weeks
The Timed Up and Go (TUG) Test is a simple and quick assessment used to evaluate mobility, balance, walking ability, and fall risk. It involves the participant sitting in a chair, standing up upon command, walking 3 meters (10 feet), turning around, walking back to the chair, and sitting down. The score consists in time taken to complete the task it is col-lected in seconds. A longer time indicates greater risk of falling.
Form the enrollment to the end of treatment at 4 weeks
Corsi Supra-Span Block Tapping Test
Time Frame: Form the enrollment to the end of treatment at 4 weeks
The Corsi Supra-Span Block Tapping Test aims to assess visuo-spatial working memory and learning processes for a number of information overcoming the short-term memory span. Placed in front of a board, where nine identical blocks have arranged, par-ticipants are required to reproduce a sequence of 9 blocks tapped by the examiner. Partici-pants can learn and recall the sequences through repeated trials, for a maximum of 18 rep-etitions. The global score is the sum of the score obtained for each stem of correct sequence.
Form the enrollment to the end of treatment at 4 weeks
Trail Making Test (TMT) A and B-A
Time Frame: Form the enrollment to the end of treatment at 4 weeks
Trail Making Test (TMT) A is a paper-and-pencil test, aimed to assess visual atten-tion, while TMT B-A score aims to assess task switching. Part A involves connecting 25 numbered circles in ascending order as quickly as possible. The time taken to complete each part is recorded in seconds, representing the score. B-A score represents the subtrac-tion among TMT B and TMT A scores (where, the part B, aimed to evaluate divided atten-tion consists in connecting 25 circles, alternating between numbers and letters - e.g., 1-A-2-B - as quickly as possible). Higher times indicate greater impairment.
Form the enrollment to the end of treatment at 4 weeks
Beck Depression Inventory (BDI)
Time Frame: Form the enrollment to the end of treatment at 4 weeks
Beck Depression Inventory (BDI) is a self-administered questionnaire, aimed to measure the depression symptoms. It consists of 21 Items, each of them item corresponds to a symptom of depression. Each item is rated on a 4-point scale (0-3). The total score ranges from 0 to 63, with higher scores indicating more severe depression.
Form the enrollment to the end of treatment at 4 weeks
State-Trait Anxiety Inventory (STAI-I) part I
Time Frame: Form the enrollment to the end of treatment at 4 weeks
State-Trait Anxiety Inventory (STAI-I) part I is a self-administered questionnaire, aimed to measure state anxiety. It consists of 20 items assessing how one feels at the evalu-ation moment. Each item is rated on a 4-point scale, with higher scores indicating greater anxiety.
Form the enrollment to the end of treatment at 4 weeks
Apathy Evaluation Scale (AES)
Time Frame: Form the enrollment to the end of treatment at 4 weeks
Apathy Evaluation Scale (AES), is a self-administered questionnaire, aimed to meas-ure the level of apathy in individuals. It consists of 18 Items (each of them rated on a 4-point scale), assessing behavioral, cognitive, and emotional aspects of goal-directed be-havior. The total score ranges from 18 to 72, with higher scores indicating greater apathy.
Form the enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Casa di Cura Villa Margherita Fresco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DWpsVMF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data (IPD) due to concerns related to patient privacy and data security. Ensuring the confidentiality and protection of our participants' personal information is a top priority. Additionally, the resources required to anonymize and manage data sharing securely are not available for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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