The Effect of High-Volume Walking With Visual Cues (VC) in Parkinson´s Disease (PD)

Parkinson´s Disease Clinical Trial

Official title:

The Effect of High-Volume Walking With Visual Cues on Gait in People With Parkinson´s Disease. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391741
• Other study ID #: 123SmOkE
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2011
• Last updated: July 11, 2011
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: University of Iceland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iceland: The National Bioethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

Other:
• Visual Cues
Walking with visual cues for 30 minutes, 4 times a week for 4 weeks
• Walking without visual cues
Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4

Locations

Country	Name	City	State
Iceland	Reykjalundur Rehabilitation Center	Mosfellsbaer

Sponsors (3)

Lead Sponsor	Collaborator
University of Iceland	Icelandic Physiotherapy Association, The Icelandic Parkinson´s Association.

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Step Length		Before, after and 3 months after a 4 week training period	No
Primary	Change in Gait Velocity		Before, after and 3 months after a 4 week training period	No
Primary	Change in Stride Time Variability		Before, after and 3 months after a 4 week training period	No
Secondary	Change in Timed Up & Go (seconds)		Before, after and 3 months after a 4 week training period	No