Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation

Parkinson's Disease Clinical Trial

Official title:

Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446549
• Other study ID #: H-3-2010-051
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: September 22, 2013
• Start date: July 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is (1) to provide quantitative information of the motor manifestations of Parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria (exercise arm):

• Idiopathic Parkinson's disease

• A stable condition the last 6 months

• Hoehn and Yahr 2 - 3

Inclusion Criteria (Deep Brain Stimulation arm):

• Patients referred to Deep Brain Stimulation

Exclusion Criteria:

• Cardiovascular disease

• Conditions that contraindicate physical exercise or the examination

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• High intensive antigravity locomotor exercise
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.

Procedure:
• Deep Brain Stimulation
Deep Brain Stimulation implantation

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Bispebjerg Hospital, Danish Parkinson Association, Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Isometric Tremor Approximate Entropy	Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.	Change from baseline up to 16 weeks	No