The Effect of High-Volume Walking With Visual Cues (VC) i... | NCT01391741

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

NCT01391741

Sponsor

University of Iceland

Status

Completed

Last Update Posted

Jul 12, 2011Estimated

Enrollment

26Actual

Phase

Phase 3

Conditions

Parkinson´s Disease

Interventions

Visual Cues
Walking without visual cues

Countries

Iceland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 11, 2011

First Posted Date

Jul 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2011

Last Update Posted Date

Jul 12, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of IcelandOTHER

Collaborators

Name	Class
The Icelandic Parkinson´s Association.	OTHER
Icelandic Physiotherapy Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Walking with visual cues	Experimental	Walking with visual cues for 30 minutes, 4 times a week for 4 weeks	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.	Other: Walking without visual cues

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual Cues	Other	Walking with visual cues for 30 minutes, 4 times a week for 4 weeks	Walking with visual cues

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Step Length		Before, after and 3 months after a 4 week training period
Change in Gait Velocity		Before, after and 3 months after a 4 week training period
Change in Stride Time Variability		Before, after and 3 months after a 4 week training period

Secondary Outcomes

Measure	Description	Time Frame
Change in Timed Up & Go (seconds)		Before, after and 3 months after a 4 week training period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

79 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andri T Sigurgeirsson, M.Sc.	University of Iceland / Reykjalundur Rehabilitation Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reykjalundur Rehabilitation Center		Mosfellsbaer		270	Iceland

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D009043	Motor Activity

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided