Clinical trial NCT03546244: Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation
Official title: Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Treadmill
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: 6 Minutes Walking Test
timeFrame: 4 week
measure: Timed up and Go Test
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona Ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
affiliation: Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: