Parkinson's Disease (PD)
Conditions
Brief summary
The purpose of this clinical research is to evaluate the effectiveness of a structured Tango-based (Riabilitango®) therapy compared to a conventional Motor Reconditioning program and a Control group in individuals diagnosed with Parkinson's Disease. The study assesses changes in motor performance, balance, gait kinematics, functional strenght, and health-related quality of life over a 3-month intervention period and a 3-month post-intervention follow-up.
Detailed description
Parkinson's disease is characterized by motor deficits affecting gait, postural control, and dynamic balance. This study compares two exercise-based rehabilitation approaches against a control group: Riabilitango® (Tango Therapy): Supervised group sessions (2 times/week, 60 minutes/session for 3 months) focusing on balance, trunk mobility, rhythm-synchronised walking, and adapted Argentine tango figures. Motor Reconditioning: Supervised small-group sessions (2 times/week, 60 minutes/session for 3 months) including cycling warm-up, progressive treadmill walking (60-70% max heart rate), upper/lower-limb functional training, and stretching exercises. Control Group: Follows usual care without participating in the structured rehabilitation interventions during the study period. Comprehensive clinical, functional, and biomechanical evaluations are conducted at baseline, monthly during the 3-month intervention period, and at a 3-month post-intervention follow-up (6 months total observation period).
Interventions
OTHERRiabilitango® Tango-based program
Supervised group tango therapy incorporating warm-up exercises, trunk mobility routines, rhythm-synchronised walking, partner activities, and progressive adapted tango patterns tailored for individuals with Parkinson's disease.
OTHERMotor Reconditioning
Supervised motor reconditioning including a cycling warm-up, progressive treadmill walking at 60-70% of age-predicted maximal heart rate, functional upper-limb exercises, and stretching routines.
Sponsors
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed clinical diagnosis of idiopathic Parkinson's Disease. * Mild to moderate disease severity (Hoehn and Yahr stage I-III). * Ability to walk independently (with or without assistive devices). * Stable antiparkinsonian pharmacological treatment for at least 4 weeks prior to enrollment. * Ability to understand study procedures and willingness to sign the Informed Consent document.
Exclusion criteria
* Severe cognitive impairment or dementia preventing comprehension of instructions or active participation. * Severe cardiovascular, respiratory, orthopedic, or other neurological conditions that impair safe exercise participation or gait evaluation. * Surgical interventions that directly affect mobility or dynamic balance (e.g., Deep Brain Stimulation or recent major orthopedic surgery). * Concurrent participation in other physical rehabilitation programs or clinical trials during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Examination Score | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | The UPDRS Part III evaluates motor function in individuals with Parkinson's disease, including speech, facial expression, tremor, rigidity, finger taps, hand movements, gait, posture, and bradykinesia. Scores range from 0 to 56, with higher scores indicating greater motor impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) Test Time | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Time in seconds taken by the participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better functional mobility. |
| Six-Minute Walk Test (6MWT) Distance | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Total distance walked in meters during 6 minutes. Higher values indicate better functional walking endurance. |
| Handgrip Strength | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Maximum isometric handgrip force measured using a digital dynamometer. Higher values indicate greater upper-limb muscle strength. |
| Sit-and-Reach Test Distance | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Lower back and hamstring flexibility evaluated via the Sit-and-Reach test. Higher values indicate better flexibility. |
| Back Scratch Test Distance | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Shoulder and upper body flexibility evaluated via the Back Scratch test. Higher values (or less negative values) indicate better shoulder flexibility. |
| Gait Speed | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Walking speed evaluated during treadmill locomotion using the Walker View system. Higher values indicate better walking capacity. |
| Step Length | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Average step length during treadmill locomotion evaluated using the Walker View system. Higher values indicate longer step length. |
| Vertical Displacement During Gait | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Vertical movement of the body center of mass during gait, evaluated using the Walker View treadmill system. |
| Postural Alignment During Gait | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Trunk alignment and posture during treadmill walking evaluated using the Walker View system. |
| Postural Sway Area | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Total ellipse area of postural sway during quiet standing with eyes open and closed, evaluated using the ProKin stabilometric platform. Lower values indicate better postural stability. |
| Center of Pressure Displacement Length | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Total trajectory length of the Center of Pressure (CoP) evaluated using the ProKin stabilometric platform under eyes open and closed conditions. Lower values indicate better static postural control. |
| Pelvic Proprioceptive Balance | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Dynamic pelvic proprioceptive control evaluated using the ProKin dynamic platform. Higher percentage scores indicate better proprioceptive stability. |
| Supine Postural Asymmetries | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Evaluation of body alignment asymmetries in a supine position using the Postural Bench system. Lower angular values indicate greater postural symmetry. |
| 39-Item Parkinson's Disease Questionnaire (PDQ-39) Summary Index | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Assessed using the 39-Item Parkinson's Disease Questionnaire (PDQ-39). The Summary Index ranges from 0% to 100%, where lower percentage scores represent better quality of life and lower disease burden. |
| 36-Item Short Form Health Survey (SF-36) Total Score | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Assessed using the 36-Item Short Form Health Survey (SF-36). Total scores range from 0 to 100, where higher scores indicate better perceived health status and overall quality of life. |
| Zung Self-Rating Depression Scale Score | Baseline, Month 1, Month 2, Month 3, and 3-month post-intervention follow-up (Month 6) | Assessed using the Zung Self-Rating Depression Scale. Total raw scores range from 20 to 80, where higher scores indicate greater severity of depressive symptoms. |
Countries
Italy
Outcome results
None listed