Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation (EMTPDR)

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Unknown

Conditions: Treadmill; Gait Disorders, Neurologic; Parkinson Disease

Treatments: Behavioral: musical treadmill; Behavioral: Traditional treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT03546244

Musical Treadmill in PD

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

musical treadmill

Experimental group

Description:

4-week daily musical treadmill training, consisting in two session, 20 minute per session

Treatment:

Behavioral: musical treadmill

traditional session

Active Comparator group

Description:

4-week daily traditional treadmill training, consisting in two session, 20 minute per session

Treatment:

Behavioral: Traditional treadmill