Parkinson DiseaseNCT03549793
Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
A study testing Dance Therapy and exercises without dance in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dance Therapy and exercises without dance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gravedona Ed Uniti, Como, 22015
Paola Ortelli, PsyD, +39 0344 82706, ortellipaola73@gmail.com
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Dance Therapy, exercises without dance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance TherapyBehavioural
the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing
exercises without danceBehavioural
the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing
| Study group | Role | What they receive |
|---|---|---|
| dance thrapy | Experimental | 4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week) Receives: Behavioral: Dance Therapy |
| exercises without dance | Active comparator | 4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week) Receives: Behavioral: exercises without dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test (TUG)
To determine fall risk and measure the progress of balance, sit to stand, and walking.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
Balance Berg Scale (BBS)
to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Apr 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549793
- Sponsor's protocol ID
- dance therapy in PD
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Dance Therapy Improve Motor Learning in Parkinson's Disease?
- ClinicalTrials.gov ID
- NCT03549793
- Acronym / sponsor ID
- dance therapy in PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| dance thrapy | Experimental | Behavioral: Dance Therapy4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week) |
| exercises without dance | Active comparator | Behavioral: exercises without dance4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Therapythe intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing | Behavioural | dance thrapy |
| exercises without dancethe intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing | Behavioural | exercises without dance |
Primary outcome
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.
2 secondary outcomes
6 Minutes Walking Test (6MWT)
Time frame: 4 weeks
Balance Berg Scale (BBS)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Frazzitta, MD principal investigator
Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Therapy and exercises without dance in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Ortelli, PsyD (3332974872, ortellipaola73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (TUG) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.