Parkinson DiseaseDWpsVMFNCT06896123
Dance Well Therapy: a Study for Evaluating Efficacy, Safety, and Feasibility
A study testing Dance Well: an artistic, multisensory dance intervention based on art and music and Conventional motor therapy group in people with Parkinson Disease, run by Casa di Cura Villa Margherita Fresco at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dance Well: an artistic, multisensory dance intervention based on art and music and Conventional motor therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fresco Parkinson Center - Villa Margherita (KOS group)
Arcugnago, VI, 36057
About this study
Official title: 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.
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.
- Conditions
- Parkinson Disease
- Being tested
- Dance Well: an artistic, multisensory dance intervention based on art and music, Conventional motor therapy group
- Keywords
- PD, Dance Well, Rehabilitation Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Well: an artistic, multisensory dance intervention based on art and musicBehavioural
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 motor therapy groupBehavioural
Conventional Motor Therapy consisted on 60-minute conventional physiotherapy, twice a week, for four weeks
| Study group | Role | What they receive |
|---|---|---|
| DanceWell Group | Experimental | 12 PD patients underwent 4-week Dance Well Program Receives: 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 Receives: Behavioral: Conventional motor therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
Secondary outcomes (8)
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
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.
Measured: Form the enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start7 Jan 2022
- Primary completion31 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Villa Margherita Fresco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giampietro Rupolo, Casa di Cura Villa Margherita Fresco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896123
- Sponsor's protocol ID
- DWpsVMF
- Acronym
- DWpsVMF
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Sulla Fattibilità e Sul Potenziale Riabilitativo Dell'Esperienza Artistica di Dance Well Nei Pazienti Affetti da Malattia di Parkinson
- ClinicalTrials.gov ID
- NCT06896123
- Acronym / sponsor ID
- DWpsVMF / DWpsVMF
- Conditions
- Parkinson Disease
- Keywords
- PD, Dance Well, Rehabilitation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Casa di Cura Villa Margherita FrescoUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DanceWell Group | Experimental | Behavioral: Dance Well: an artistic, multisensory dance intervention based on art and music12 PD patients underwent 4-week Dance Well Program |
| Conventional Therapy Group | Active comparator | Behavioral: Conventional motor therapy group12 PD patients underwent 4-week Conventional Therapy Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Well: an artistic, multisensory dance intervention based on art and musicDW 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 | Behavioural | DanceWell Group |
| Conventional motor therapy groupConventional Motor Therapy consisted on 60-minute conventional physiotherapy, twice a week, for four weeks | Behavioural | Conventional Therapy Group |
Primary outcome
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.
8 secondary outcomes
Berg Balance Scale (BBS)
Time frame: 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
Timed Up and Go (TUG) Test
Time frame: 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
Trail Making Test (TMT) A and B-A
Time frame: 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
State-Trait Anxiety Inventory (STAI-I) part I
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Well: an artistic, multisensory dance intervention based on art and music and Conventional motor therapy group in people with Parkinson Disease, run by Casa di Cura Villa Margherita Fresco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS III (time frame: Form the enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.