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

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ClinicalTrials.gov Identifier: NCT01446549
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : September 24, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: High intensive antigravity locomotor exercise Procedure: Deep Brain Stimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation
Study Start Date : July 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Deep Brain Stimulation Procedure: Deep Brain Stimulation
Deep Brain Stimulation implantation
Experimental: Locomotor Exercise Other: High intensive antigravity locomotor exercise
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Change in Isometric Tremor Approximate Entropy [ Time Frame: Change from baseline up to 16 weeks ]
    Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446549


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Bispebjerg Hospital
Danish Parkinson Association
Investigators
Principal Investigator: Martin H Rose, MSci Department of Exercise and Sport Sciences, University of Copenhagen
Study Chair: Bente R Jensen, MSci, PhD Department of Exercise and Sport Sciences, University of Copenhagen
Study Chair: Stig Sonne-Holm, MD, DSc Department of Orthopedic Surgery, Hvidovre University Hospital
Study Chair: Annemette Løkkegaard, MD, PhD Department of Neurology, Bispebjerg University Hospital
More Information

Responsible Party: Martin Hoyer Rose, Principal Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01446549     History of Changes
Other Study ID Numbers: H-3-2010-051
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases