NCT00549406

Brief Summary

The ability to maintain balance and avoid falling is highly dependent on the ability to locate objects and architectural features in the environment. This need to continually monitor the environment as one moves about in daily life suggests a critical role for visual attention, gaze control, and spatial memory, all of which are known to decline with aging. In this study, the investigators will test the efficacy of a computer-based visual-training program designed to improve the ability to rapidly extract information from the peripheral visual field. It is expected that older adults involved in the visual training intervention will improve the speed, accuracy, and effectiveness of reach-to-grasp balance-recovery reactions evoked by sudden unpredictable balance perturbation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

3.1 years

First QC Date

October 24, 2007

Last Update Submit

December 19, 2014

Conditions

Accidental FallsMusculoskeletal Equilibrium

Keywords

VisionVisual attentionPostural balanceGeriatrics

Outcome Measures

Primary Outcomes (1)

  • ability to use peripheral vision to recover balance by grasping a handhold

    within one week of starting and completing the intervention

Secondary Outcomes (1)

  • natural gaze and balance-recovery behavior (in responding to a sudden unpredictable balance perturbation while walking in an unfamiliar environment); clinical balance measures; visual-processing measures

    within one week of starting and completing the intervention

Study Arms (3)

1

EXPERIMENTAL

computer-based visual-training program UFOV

Procedure: computerized visual training

2

EXPERIMENTAL

video-game based visual training

Procedure: video-game based visual training

3

PLACEBO COMPARATOR

computerized word puzzles

Procedure: computerized word puzzles

Interventions

computerized visual trainingPROCEDURE

two one-hour training sessions per week, for five consecutive weeks

Also known as: "Useful Field of View" (UFOV) training
1
computerized word puzzlesPROCEDURE

two one-hour sessions per week, for five consecutive weeks

Also known as: "Super Text-Twist" puzzles
3
video-game based visual trainingPROCEDURE

two one-hour training sessions per week, for five consecutive weeks

Also known as: Video game training
2

Eligibility Criteria

Age64 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community dwelling
  • Functional mobility (no dependence on mobility aids)
  • Impaired visual processing (UFOV divided attention score of 200ms or worse)

You may not qualify if:

  • Neurological or musculoskeletal disorder
  • Cognitive disorder (e.g. dementia)
  • Uncorrected visual impairments
  • Recurrent dizziness or unsteadiness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Studies in Aging, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

  • Brian E Maki, PhD, PEng

    Sunnybrook Health Sciences Centre, University of Toronto

    PRINCIPAL INVESTIGATOR

  • Sandra M McKay, PhD

    Sunnybrook Health Sciences Centre, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

June 1, 2008

Primary Completion

July 1, 2011

Study Completion

February 1, 2012

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

CA(1)