Back to resultsCan Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dance Therapy
exercises without dance
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;
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;
- cognitive decline (MMSE correct score < 24)
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
dance thrapy
exercises without dance
Arm Description
4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)
4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week)
Outcomes
Primary Outcome Measures
Timed Up and Go Test (TUG)
To determine fall risk and measure the progress of balance, sit to stand, and walking.
Secondary Outcome Measures
6 Minutes Walking Test (6MWT)
The 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.
Balance Berg Scale (BBS)
to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Full Information
NCT ID
NCT03549793
First Posted
May 7, 2018
Last Updated
June 7, 2018
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT03549793
Brief Title
Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
Official Title
Can Dance Therapy Improve Motor Learning in Parkinson's Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to experimental group or control group. Both of the groups undergo a rehabilitation treatment. The experimental group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + dance therapy. The control group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + exercises
Masking
Investigator
Masking Description
The investigator are neurologists, blinded to the treatment received by the patient
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dance thrapy
Arm Type
Experimental
Arm Description
4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)
Arm Title
exercises without dance
Arm Type
Active Comparator
Arm Description
4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week)
Intervention Type
Behavioral
Intervention Name(s)
Dance Therapy
Intervention Description
the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing
Intervention Type
Behavioral
Intervention Name(s)
exercises without dance
Intervention Description
the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing
Primary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
To determine fall risk and measure the progress of balance, sit to stand, and walking.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
6 Minutes Walking Test (6MWT)
Description
The 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 weeks
Title
Balance Berg Scale (BBS)
Description
to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
delayed recall of items
Description
number of specific items correctly performed in recall phase
Time Frame
4 weeks
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;
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;
cognitive decline (MMSE correct score < 24)
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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