Dance Exercise as Novel Complementary Therapy for Parkins... | NCT01163344

Studies
Dance Exercise as Novel Complementary Therapy for Parkinson's Disease

NCT01163344

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Mar 16, 2017Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Parkinsons Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jul 14, 2010

First Posted Date

Jul 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniel Tarsy, Principal Investigator, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.

Detailed Description

Comparison of traditional PT to dance in people who have parkinsons disease to measure which is better for gait, balance and QOL.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dance Therapy Group		This will group will undergo dance therapy once a week for a series of 8 weeks.
Physical Therapy Group		This group will undergo physical therapy sessions once a week for a series of 8 weeks

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Balance and Gait improvement	We seek to determine if balance and gait are improved as a result of dance therapy. This will be compared to the balance and gait data of group physical therapy.	10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of PD at least 3 years ago
Less than 80 years of age
Have gait and balance issues

Exclusion Criteria:

Diagnosis of PD for less than 3 years
80 years of age or older
Not have gait and balance issues

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

To qualify for this study, subject must have been diagnosed with Parkinson's Disease for 3 years or more, be less than 80 years of age, and have problems with gait and balance

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Tarsy, MD	Beth Israel Deaconess Medical Center	Principal Investigator
Veronique Vanderhorst, MD, PhD	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided