NCT03549793

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

May 7, 2018

Last Update Submit

June 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go Test (TUG)

    To determine fall risk and measure the progress of balance, sit to stand, and walking.

    4 weeks

Secondary Outcomes (2)

  • 6 Minutes Walking Test (6MWT)

    4 weeks

  • Balance Berg Scale (BBS)

    4 weeks

Other Outcomes (1)

  • delayed recall of items

    4 weeks

Study Arms (2)

dance thrapy

EXPERIMENTAL

4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)

Behavioral: Dance Therapy

exercises without dance

ACTIVE COMPARATOR

4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week)

Behavioral: exercises without dance

Interventions

Dance TherapyBEHAVIORAL

the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing

dance thrapy

the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing

exercises without dance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

Gravedona Ed Uniti, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dance TherapyExercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareExercise Movement TechniquesPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Ortelli, PsyD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator are neurologists, blinded to the treatment received by the patient
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 8, 2018

Study Start

April 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

June 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations