- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391741
The Effect of High-Volume Walking With Visual Cues (VC) in Parkinson´s Disease (PD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Mosfellsbaer, Iceland, 270
- Reykjalundur Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking with visual cues
Walking with visual cues for 30 minutes, 4 times a week for 4 weeks
|
Walking with visual cues for 30 minutes, 4 times a week for 4 weeks
|
|
Active Comparator: Walking without visual cues
Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4 times a week for 4 weeks.
|
Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Step Length
Time Frame: Before, after and 3 months after a 4 week training period
|
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
|
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
|
Before, after and 3 months after a 4 week training period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Timed Up & Go (seconds)
Time Frame: Before, after and 3 months after a 4 week training period
|
Before, after and 3 months after a 4 week training period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andri T Sigurgeirsson, M.Sc., University of Iceland / Reykjalundur Rehabilitation Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123SmOkE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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