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CompletedNCT06896123DWpsVMFUpdated Mar 26, 2025

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

An interventional study of Dance Well: an artistic, multisensory dance intervention based on art and music and Conventional motor therapy group in Parkinson Disease, sponsored by Casa di Cura Villa Margherita Fresco. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Casa di Cura Villa Margherita Fresco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Jan 2022, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Parkinson Disease

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Keywords

  • PD
  • Dance Well
  • Rehabilitation Therapy
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Casa di Cura Villa Margherita Fresco as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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

  • Active comparator
    Conventional Therapy Group

    12 PD patients underwent 4-week Conventional Therapy Program

    Behavioral: Conventional motor therapy group

Interventions

  • BehavioralDance 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

  • BehavioralConventional motor therapy group

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

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What researchers measure

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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. Berg Balance Scale (BBS)

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  2. 6-Minute Walk Test (6MWT)

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  3. Timed Up and Go (TUG) Test

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  4. Corsi Supra-Span Block Tapping Test

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  5. Trail Making Test (TMT) A and B-A

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  6. Beck Depression Inventory (BDI)

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  7. State-Trait Anxiety Inventory (STAI-I) part I

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

  8. Apathy Evaluation Scale (AES)

    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.

    Time frame: Form the enrollment to the end of treatment at 4 weeks

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Study locations

1 site
  • Fresco Parkinson Center - Villa Margherita (KOS group)
    Arcugnago, VI 36057, Italy
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References and documents

Related links

Individual participant data

Plan to share: No — 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06896123
Lead sponsor
Casa di Cura Villa Margherita Fresco
Responsible party
Giampietro Rupolo (President of KOS Medical Group, Casa di Cura Villa Margherita Fresco) — Principal investigator
First posted
Mar 26, 2025
Start date
Jan 7, 2022
Primary completion
May 31, 2022
Completion
Sep 30, 2022
Last update
Mar 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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