Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation

NCT03546244 | Unknown

• 1 other identifier: Musical Treadmill in PD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Treadmill

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

musical treadmill

EXPERIMENTAL

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

Behavioral: musical treadmill

traditional session

ACTIVE COMPARATOR

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

Behavioral: Traditional treadmill

Interventions

musical treadmill BEHAVIORAL

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

musical treadmill

Traditional treadmill BEHAVIORAL

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

traditional session

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

Gravedona Ed Uniti, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Frazzitta, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Ortelli, PsyD

CONTACT

3332974872; ortellipaola73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 6, 2018
• Study Start: January 3, 2018
• Primary Completion: January 3, 2018
• Study Completion: January 3, 2019
• Last Updated: June 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)