Parkinson DiseaseFOGNCT01887054
Freezing of Gait in Parkinson's Disease
A study testing Tower of Hanoi in people with Parkinson Disease, run by Duke University at 1 site in United States.
Trial summary
This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Tower of Hanoi
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: greater than 18 years old and without an upper age limit
- diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
- Ambulate independently without an assistive device for at least 60 meters
- Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
- Willingness and ability to participate in training and complete training diary
- Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
- Ability to sign informed consent
- Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus
Who cannot join
- Inability to complete questionnaires
- Unwillingness to participate in training, complete all questionnaires and training diary
- Subjects with secondary causes of parkinsonism
- Significant dementia (MOCA <20)
- Prior deep brain stimulation (DBS) surgery or pallidotomy
- Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
- Subjects cannot start any new medications during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease
This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.
Read the detailed description
This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).
This study will involve 2 study groups:
Group A - training group; Group B - no training group/controls.
Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.
Participation in this study is expected to last 6-8 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Tower of Hanoi, Placebo group - non use of Tower of Hanoi
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tower of HanoiDevice
Placebo group - non use of Tower of HanoiOther
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Active comparator | There are 2 study visits. Subjects in this group will complete the following:
Visit 1
* Gait evaluation
* Neuropsychological testing
* Questionnaires and assessments
* Taught how to complete a visual problem-solving task (Tower of Hanoi)
* Given a diary to record training at home.
In-home
•For 6 weeks at home, complete the in-home visual problem-solving tasks as instructed at Visit 1
Visit 2
* Gait evaluation
* Neuropsychological testing
* Questionnaires and assessments Receives: Device: Tower of Hanoi |
| Non Training Group | Placebo comparator | There are 2 study visits. Subjects in this group will complete the following:
Visit 1
* Gait evaluation
* Neuropsychological testing
* Questionnaires and assessments
Visit 2
* Gait evaluation
* Neuropsychological testing
* Questionnaires and assessments Receives: Other: Placebo group - non use of Tower of Hanoi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Limb Support (DLS)
Primary outcome will be the percent of the gait cycle spent in DLS. This will be evaluated using a GaitRite via a continuous walk, with subjects walking an 18-20 meter oval loop three times continuously.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Stacy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887054
- Sponsor's protocol ID
- Pro00045495
- Acronym
- FOG
- Status last verified
- Jan 2017
- First submitted
- 19 Jun 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01887054
- Acronym / sponsor ID
- FOG / Pro00045495
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jun 2013 (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.
This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.
Detailed description
This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).
This study will involve 2 study groups:
Group A - training group; Group B - no training group/controls.
Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.
Participation in this study is expected to last 6-8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Active comparator | Device: Tower of HanoiThere are 2 study visits. Subjects in this group will complete the following: Visit 1 * Gait evaluation * Neuropsychological testing * Questionnaires and assessments * Taught how to complete a visual problem-solving task (Tower of Hanoi) * Given a diary to record training at home. In-home •For 6 weeks at home, complete the in-home visual problem-solving tasks as instructed at Visit 1 Visit 2 * Gait evaluation * Neuropsychological testing * Questionnaires and assessments |
| Non Training Group | Placebo comparator | Other: Placebo group - non use of Tower of HanoiThere are 2 study visits. Subjects in this group will complete the following: Visit 1 * Gait evaluation * Neuropsychological testing * Questionnaires and assessments Visit 2 * Gait evaluation * Neuropsychological testing * Questionnaires and assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: greater than 18 years old and without an upper age limit
- diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
- Ambulate independently without an assistive device for at least 60 meters
- Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
- Willingness and ability to participate in training and complete training diary
Key exclusion criteria (7 listed)
- Inability to complete questionnaires
- Unwillingness to participate in training, complete all questionnaires and training diary
- Subjects with secondary causes of parkinsonism
- Significant dementia (MOCA <20)
- Prior deep brain stimulation (DBS) surgery or pallidotomy
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 |
|---|---|---|
| Tower of Hanoi | Device | Training Group |
| Placebo group - non use of Tower of Hanoi | Other | Non Training Group |
Primary outcome
Double Limb Support (DLS)
Time frame: 6 weeks
Primary outcome will be the percent of the gait cycle spent in DLS. This will be evaluated using a GaitRite via a continuous walk, with subjects walking an 18-20 meter oval loop three times continuously.
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 Jan 2017.
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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.
Mark Stacy, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tower of Hanoi in people with Parkinson Disease, run by Duke University at 1 site in United States.
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 8 inclusion and 7 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 Jan 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Double Limb Support (DLS) (time frame: 6 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 Jan 2017.