Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation (EMTPDR)
Primary Purpose
Parkinson Disease, Gait Disorders, Neurologic, Treadmill
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
musical treadmill
Traditional treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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;
Sites / Locations
- Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
musical treadmill
traditional session
Arm Description
4-week daily musical treadmill training, consisting in two session, 20 minute per session
4-week daily traditional treadmill training, consisting in two session, 20 minute per session
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03546244
First Posted
May 8, 2018
Last Updated
June 4, 2018
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT03546244
Brief Title
Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation
Acronym
EMTPDR
Official Title
Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
January 3, 2018 (Actual)
Study Completion Date
January 3, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic, Treadmill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
musical treadmill
Arm Type
Experimental
Arm Description
4-week daily musical treadmill training, consisting in two session, 20 minute per session
Arm Title
traditional session
Arm Type
Active Comparator
Arm Description
4-week daily traditional treadmill training, consisting in two session, 20 minute per session
Intervention Type
Behavioral
Intervention Name(s)
musical treadmill
Intervention Description
Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill
Intervention Type
Behavioral
Intervention Name(s)
Traditional treadmill
Intervention Description
Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill
Primary Outcome Measure Information:
Title
6 Minutes Walking Test
Description
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
Time Frame
4 week
Title
Timed up and Go Test
Description
The TUG is aimed to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning
Time Frame
4 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Ortelli, PsyD
Phone
3332974872
Email
ortellipaola73@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
City
Gravedona Ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Ortelli, PsyD
Phone
+39 0344 82706
Email
ortellipaola73@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation
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