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Clinical Trials/NCT01391741
NCT01391741CompletedPhase 3

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

University of Iceland1 site in 1 country26 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Change in Step Length

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 79 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Walking with visual cues

Experimental

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

Intervention: Visual Cues (Other)

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.

Intervention: Walking without visual cues (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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