Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2019-01-03

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Parkinson Disease Gait Disorders, Neurologic Treadmill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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musical treadmill

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

Group Type EXPERIMENTAL

musical treadmill

Intervention Type BEHAVIORAL

Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill

traditional session

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

Group Type ACTIVE_COMPARATOR

Traditional treadmill

Intervention Type BEHAVIORAL

Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill

Interventions

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musical treadmill

Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill

Intervention Type BEHAVIORAL

Traditional treadmill

Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Luca Sebastianelli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy