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

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

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

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Gait Disorders, Neurologic; Treadmill
• Intervention / Treatment: Behavioral: musical treadmill; Behavioral: Traditional treadmill

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como
    • Gravedona Ed Uniti, Como, Italy, 22015
      • Recruiting
      • Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: musical treadmill; 4-week daily musical treadmill training, consisting in two session, 20 minute per session	Behavioral: musical treadmill; Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill
ACTIVE_COMPARATOR: traditional session; 4-week daily traditional treadmill training, consisting in two session, 20 minute per session	Behavioral: Traditional treadmill; Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill

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

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2018
• Primary Completion (ACTUAL): January 3, 2018
• Study Completion (ANTICIPATED): January 3, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: Musical Treadmill in PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No