- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549793
Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
June 7, 2018 updated by: Ospedale Generale Di Zona Moriggia-Pelascini
Can Dance Therapy Improve Motor Learning in Parkinson's Disease?
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Como
-
Gravedona Ed Uniti, Como, Italy, 22015
- Recruiting
- Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
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;
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dance thrapy
4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)
|
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)
|
the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delayed recall of items
Time Frame: 4 weeks
|
number of specific items correctly performed in recall phase
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 30, 2018
Study Registration Dates
First Submitted
May 7, 2018
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 8, 2018
Study Record Updates
Last Update Posted (Actual)
June 8, 2018
Last Update Submitted That Met QC Criteria
June 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dance therapy 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.