Parkinson's DiseaseNCT01446549
Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
A study testing High intensive antigravity locomotor exercise and Deep Brain Stimulation in people with Parkinson's Disease, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- High intensive antigravity locomotor exercise and Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- A stable condition the last 6 months
- Hoehn and Yahr 2 - 3
- Patients referred to Deep Brain Stimulation
Who cannot join
- Cardiovascular disease
- Conditions that contraindicate physical exercise or the examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor 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.
- Conditions
- Parkinson's Disease
- Being tested
- High intensive antigravity locomotor exercise, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensive antigravity locomotor exerciseOther
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.
Deep Brain StimulationProcedure or surgery
Deep Brain Stimulation implantation
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Not described Receives: Procedure: Deep Brain Stimulation |
| Locomotor Exercise | Experimental | Not described Receives: Other: High intensive antigravity locomotor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Bispebjerg Hospital, Danish Parkinson Association
- Responsible party
- Principal investigator, Martin Hoyer Rose, University of Copenhagen
- Investigators
- Martin H Rose, MSci, Principal investigator, Department of Exercise and Sport Sciences, University of CopenhagenBente R Jensen, MSci, PhD, Study chair, Department of Exercise and Sport Sciences, University of CopenhagenStig Sonne-Holm, MD, DSc, Study chair, Department of Orthopedic Surgery, Hvidovre University HospitalAnnemette Løkkegaard, MD, PhD, Study chair, Department of Neurology, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446549
- Sponsor's protocol ID
- H-3-2010-051
- Status last verified
- Sep 2013
- First submitted
- 29 Sep 2011
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT01446549
- Acronym / sponsor ID
- H-3-2010-051
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Bispebjerg Hospital, Danish Parkinson Association
- Study start
- Jul 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep Brain Stimulation |
| Locomotor Exercise | Experimental | Other: High intensive antigravity locomotor exercise |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease
- A stable condition the last 6 months
- Hoehn and Yahr 2 - 3
- Patients referred to Deep Brain Stimulation
Key exclusion criteria (2 listed)
- Cardiovascular disease
- Conditions that contraindicate physical exercise or the examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensive antigravity locomotor exerciseHigh intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks. | Other | Locomotor Exercise |
| Deep Brain StimulationDeep Brain Stimulation implantation | Procedure or surgery | Deep Brain Stimulation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin H Rose, MSci principal investigator
Department of Exercise and Sport Sciences, University of Copenhagen
Bente R Jensen, MSci, PhD study chair
Department of Exercise and Sport Sciences, University of Copenhagen
Stig Sonne-Holm, MD, DSc study chair
Department of Orthopedic Surgery, Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensive antigravity locomotor exercise and Deep Brain Stimulation in people with Parkinson's Disease, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Isometric Tremor Approximate Entropy (time frame: Change from baseline up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.