Parkinson´s DiseasePhase 3NCT01391741
The Effect of High-Volume Walking With Visual Cues (VC) in Parkinson´s Disease (PD)
A Phase 3 study testing Visual Cues and Walking without visual cues in people with Parkinson´s Disease, run by University of Iceland at 1 site in Iceland.
Trial summary
People with disease (PD) tend to walk with short steps, decreased velocity, and increased stride time variability. Short steps and increased variability are related to greater fall risk. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Parkinson´s Disease
- What is being tested?
- Visual Cues and Walking without visual cues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIceland
- Study dates
- Apr 2008to Sep 2008
- Phase
- Phase 3
- 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 Up to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a confirmed diagnosis of PD according to the UK Parkinson´s Disease Society Brain Bank Clinical Diagnostic Criteria (18)
- <80 years of age
- community residing
- Hoehn and Yahr (HY) stage 2-3
- Mini Mental State Examination (MMSE) score of >23
- ability to walk without walking aids for a total of 20 minutes over a 30-minute period
Who cannot join
- major modifications of Parkinson´s medication (Madopar >200 mg/d or >20% increase in Dopamine agonists) 3 weeks prior to baseline assessment
- comorbidities or disabilities, which might influence walking
- a history of brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-Volume Walking With Visual Cues on Gait in People With Parkinson´s Disease. A Randomized Controlled Trial
People with disease (PD) tend to walk with short steps, decreased velocity, and increased stride time variability. Short steps and increased variability are related to greater fall risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked effects on gait in people with PD which is considered to reflect an impaired automaticity of gait.
Objective: To investigate short and long term effects of high-volume walking with visual spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with Parkinson´s Disease (PD), compared with walking without VSC.
- Conditions
- Parkinson´s Disease
- Being tested
- Visual Cues, Walking without visual cues
- Keywords
- Parkinson´s Disease, Walking, Exercise, Automaticity, Dual Task, Visual Cues, Cueing, Neuroplasticity, Gait analysis
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual CuesOther
Walking with visual cues for 30 minutes, 4 times a week for 4 weeks
Walking without visual cuesOther
Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4
| Study group | Role | What they receive |
|---|---|---|
| Walking with visual cues | Experimental | Walking with visual cues for 30 minutes, 4 times a week for 4 weeks Receives: Other: Visual Cues |
| Walking without visual cues | Active comparator | Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4 times a week for 4 weeks. Receives: Other: Walking without visual cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Step Length
Measured: Before, after and 3 months after a 4 week training period
Change in Gait Velocity
Measured: Before, after and 3 months after a 4 week training period
Change in Stride Time Variability
Measured: Before, after and 3 months after a 4 week training period
Secondary outcomes (1)
Change in Timed Up & Go (seconds)
Measured: Before, after and 3 months after a 4 week training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- The Icelandic Parkinson´s Association., Icelandic Physiotherapy Association
- Investigators
- Andri T Sigurgeirsson, M.Sc., Principal investigator, University of Iceland / Reykjalundur Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391741
- Sponsor's protocol ID
- 123SmOkE
- Status last verified
- Mar 2010
- First submitted
- 7 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Volume Walking With Visual Cues on Gait in People With Parkinson´s Disease. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01391741
- Acronym / sponsor ID
- 123SmOkE
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s Disease, Walking, Exercise, Automaticity, Dual Task, Visual Cues, Cueing, Neuroplasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- The Icelandic Parkinson´s Association., Icelandic Physiotherapy Association
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Jul 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.
People with disease (PD) tend to walk with short steps, decreased velocity, and increased stride time variability. Short steps and increased variability are related to greater fall risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked effects on gait in people with PD which is considered to reflect an impaired automaticity of gait.
Objective: To investigate short and long term effects of high-volume walking with visual spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with Parkinson´s Disease (PD), compared with walking without VSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking with visual cues | Experimental | Other: Visual CuesWalking with visual cues for 30 minutes, 4 times a week for 4 weeks |
| Walking without visual cues | Active comparator | Other: Walking without visual cuesWalking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4 times a week for 4 weeks. |
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- a confirmed diagnosis of PD according to the UK Parkinson´s Disease Society Brain Bank Clinical Diagnostic Criteria (18)
- <80 years of age
- community residing
- Hoehn and Yahr (HY) stage 2-3
- Mini Mental State Examination (MMSE) score of >23
Key exclusion criteria (3 listed)
- major modifications of Parkinson´s medication (Madopar >200 mg/d or >20% increase in Dopamine agonists) 3 weeks prior to baseline assessment
- comorbidities or disabilities, which might influence walking
- a history of brain surgery
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 |
|---|---|---|
| Visual CuesWalking with visual cues for 30 minutes, 4 times a week for 4 weeks | Other | Walking with visual cues |
| Walking without visual cuesWalking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4 | Other | Walking without visual cues |
Primary outcome
Change in Step Length
Time frame: Before, after and 3 months after a 4 week training period
Change in Gait Velocity
Time frame: Before, after and 3 months after a 4 week training period
Change in Stride Time Variability
Time frame: Before, after and 3 months after a 4 week training period
1 secondary outcome
Change in Timed Up & Go (seconds)
Time frame: Before, after and 3 months after a 4 week training period
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 12 Jul 2011.
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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.
Andri T Sigurgeirsson, M.Sc. principal investigator
University of Iceland / Reykjalundur Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Visual Cues and Walking without visual cues in people with Parkinson´s Disease, run by University of Iceland at 1 site in Iceland.
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 6 inclusion and 3 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 12 Jul 2011. 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 Iceland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Step Length (time frame: Before, after and 3 months after a 4 week training period). The study lists 3 primary outcomes in all. 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 12 Jul 2011.