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Completed

NCT Number: NCT01446549

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High intensive antigravity locomotor exercise

Other

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

Deep Brain Stimulation

Procedure

Deep Brain Stimulation implantation

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Bispebjerg Hospital
  • Danish Parkinson Association
  • Hvidovre University Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2011
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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