Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 24, 2013
September 1, 2013
3.2 years
September 29, 2011
September 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Deep Brain Stimulation
EXPERIMENTALLocomotor Exercise
EXPERIMENTALInterventions
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease
- A stable condition the last 6 months
- Hoehn and Yahr 2 - 3
- Patients referred to Deep Brain Stimulation
You may not qualify if:
- Cardiovascular disease
- Conditions that contraindicate physical exercise or the examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Hvidovre University Hospitalcollaborator
- Bispebjerg Hospitalcollaborator
- Danish Parkinson Associationcollaborator
Study Sites (1)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 5, 2011
Study Start
July 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 24, 2013
Record last verified: 2013-09