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

Primary Purpose

Parkinson´s Disease

Status

Completed

Phase

Phase 3

Locations

Iceland

Study Type

Interventional

Intervention

Visual Cues

Walking without visual cues

About this trial

This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s Disease, Walking, Exercise, Automaticity, Dual Task, Visual Cues, Cueing, Neuroplasticity, Gait analysis

Eligibility Criteria

undefined - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Reykjalundur Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walking with visual cues

Walking without visual cues

Arm Description

Walking with visual cues 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 times a week for 4 weeks.

Outcomes

Primary Outcome Measures

Change in Step Length

Change in Gait Velocity

Change in Stride Time Variability

Secondary Outcome Measures

Change in Timed Up & Go (seconds)

Full Information

NCT ID

NCT01391741

First Posted

July 7, 2011

Last Updated

July 11, 2011

Sponsor

University of Iceland

Collaborators

The Icelandic Parkinson´s Association., Icelandic Physiotherapy Association

1. Study Identification

Unique Protocol Identification Number

NCT01391741

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Iceland

Collaborators

The Icelandic Parkinson´s Association., Icelandic Physiotherapy Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson´s Disease

Keywords

Parkinson´s Disease, Walking, Exercise, Automaticity, Dual Task, Visual Cues, Cueing, Neuroplasticity, Gait analysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Walking with visual cues

Arm Type

Experimental

Arm Description

Walking with visual cues for 30 minutes, 4 times a week for 4 weeks

Arm Title

Walking without visual cues

Arm Type

Active Comparator

Arm Description

Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4 times a week for 4 weeks.

Intervention Type

Other

Intervention Name(s)

Visual Cues

Intervention Description

Walking with visual cues for 30 minutes, 4 times a week for 4 weeks

Intervention Type

Other

Intervention Name(s)

Walking without visual cues

Intervention Description

Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4

Primary Outcome Measure Information:

Title

Change in Step Length

Time Frame

Before, after and 3 months after a 4 week training period

Title

Change in Gait Velocity

Time Frame

Before, after and 3 months after a 4 week training period

Title

Change in Stride Time Variability

Time Frame

Before, after and 3 months after a 4 week training period

Secondary Outcome Measure Information:

Title

Change in Timed Up & Go (seconds)

Time Frame

Before, after and 3 months after a 4 week training period

10. Eligibility

Sex

All

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andri T Sigurgeirsson, M.Sc.

Organizational Affiliation

University of Iceland / Reykjalundur Rehabilitation Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reykjalundur Rehabilitation Center

City

Mosfellsbaer

ZIP/Postal Code

270

Country

Iceland

12. IPD Sharing Statement

Learn more about this trial

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

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