Fresco Parkinson Center - Villa Margherita (KOS group)
Arcugnago, VI, 36057, Italy
NCT Number: NCT06896123
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Arcugnago, VI, 36057, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 consisted on 60-minute conventional physiotherapy, twice a week, for four weeks
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.
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.
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.
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.
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.
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.
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.
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.
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.
Casa di Cura Villa Margherita Fresco
Other
Studio Sulla Fattibilità e Sul Potenziale Riabilitativo Dell'Esperienza Artistica di Dance Well Nei Pazienti Affetti da Malattia di Parkinson
Acronym: DWpsVMF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06133283
Basal Ganglia Diseases, Brain Diseases
San Antonio, Texas, United States
View Trial DetailsNCT05766813
Basal Ganglia Diseases, Brain Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07723027
Basal Ganglia Diseases, Brain Diseases
Shakargarh, Punjab Province, Pakistan
View Trial DetailsNCT07361250
Basal Ganglia Diseases, Brain Diseases
Wuhan, Hubei, China
View Trial Details