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Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?

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ClinicalTrials.gov Identifier: NCT03549793
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ospedale Generale Di Zona Moriggia-Pelascini

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Dance Therapy Behavioral: exercises without dance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Investigator)
Masking Description: The investigator are neurologists, blinded to the treatment received by the patient
Primary Purpose: Treatment
Official Title: Can Dance Therapy Improve Motor Learning in Parkinson's Disease?
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dance thrapy
4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)
Behavioral: Dance Therapy
the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing

Active Comparator: exercises without dance
4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week)
Behavioral: exercises without dance
the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing




Primary Outcome Measures :
  1. Timed Up and Go Test (TUG) [ Time Frame: 4 weeks ]
    To determine fall risk and measure the progress of balance, sit to stand, and walking.


Secondary Outcome Measures :
  1. 6 Minutes Walking Test (6MWT) [ Time Frame: 4 weeks ]
    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.

  2. Balance Berg Scale (BBS) [ Time Frame: 4 weeks ]
    to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.


Other Outcome Measures:
  1. delayed recall of items [ Time Frame: 4 weeks ]
    number of specific items correctly performed in recall phase



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549793


Contacts
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Contact: Paola Ortelli, PsyD 3332974872 ortellipaola73@gmail.com

Locations
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Italy
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital Recruiting
Gravedona Ed Uniti, Como, Italy, 22015
Contact: Paola Ortelli, PsyD    +39 0344 82706    ortellipaola73@gmail.com   
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
Investigators
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Principal Investigator: 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

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Responsible Party: Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT03549793     History of Changes
Other Study ID Numbers: dance therapy in PD
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases