Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation

Study Overview
=================
Brief Summary
-----------------
In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training

Detailed Description
-----------------
Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training is useful in improving the gait's parameters in patients in early-moderate stages of disease. Moreover, it has been shown that the music, exploiting the entrainment, is effective in order to ameliorate several gait parameters, as step lenghts and cadence. No data are available about the effectiveness of the association between treadmill and music. The aim of this study is to evaluate the effect of a gait training using musical treadmill in patients in stages I-II-III Hoehn & Yahr (H&Y). 100 patients with PD in early-moderate stage of disease will be enrolled. All patients will undergo an intensive treatment: 2 session of 20-minutes treadmill training per day, 5 times a week, for 4 weeks. Treadmill speed will be previously set at 20% less the confidence speed and progressively increased of 20%. All patients will be evaluat at the enrolment and at the end of the treatment. The outcome misures are: 6 Minute Walking Test and Timed Up and Go Test.

Official Title
-----------------
Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Gait Disorders, Neurologic, Treadmill

Intervention / Treatment
-----------------
* Behavioral: musical treadmill
* Behavioral: Traditional treadmill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 2.5-3 according to the Hoehn and Yahr scale (H&Y); Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization; Mini Mental State Examination (MMSE) ≥ 24; Exclusion Criteria: Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months; Drug-induced dyskinesias; Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III; Behavioral disturbances (evaluated with Neuropsychiatric Inventory); Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: musical treadmill<br>4-week daily musical treadmill training, consisting in two session, 20 minute per session | Behavioral: musical treadmill<br>* Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill<br>|
| Active Comparator: traditional session<br>4-week daily traditional treadmill training, consisting in two session, 20 minute per session | Behavioral: Traditional treadmill<br>* Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walking Test | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes | 4 week | 
| Timed up and Go Test | The TUG is aimed to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning | 4 week |