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

NCT01391741 | Completed Phase 3

• 1 other identifier: 123SmOkE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson´s Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 (1)

• Change in Timed Up & Go (seconds)

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

Study Arms (2)

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

Visual Cues OTHER

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

Walking with visual cues

Walking without visual cues OTHER

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

Walking without visual cues

Eligibility Criteria

• Age: Up to 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• The Icelandic Parkinson´s Association.: collaborator
• Icelandic Physiotherapy Association: collaborator

Study Sites (1)

Reykjalundur Rehabilitation Center

Mosfellsbaer, 270, Iceland

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Andri T Sigurgeirsson, M.Sc.

  University of Iceland / Reykjalundur Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 12, 2011

Record last verified: 2010-03

Locations

IC (1)