NCT01607736

Brief Summary

Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. The investigators hypothesize that virtual gait training in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

3 months

First QC Date

May 16, 2012

Last Update Submit

May 29, 2012

Conditions

Keywords

fallswalkinghealthy older individualsvirtual gait training

Outcome Measures

Primary Outcomes (1)

  • gait speed

    gait speed measure with GAITRite® electronic walkway system

    Change from baseline in gait speed at 3 weeks

Secondary Outcomes (1)

  • fear of falling

    change from baseline at end of week 3

Study Arms (2)

Inactive Comparator

NO INTERVENTION

Virtual Gait Training

EXPERIMENTAL
Behavioral: Virtual Gait Training

Interventions

The intervention consisted of 12-minute virtual gait training sessions once daily for a total of 14 weekdays within a three-week period. The intervention video showed walking legs of a 30-year-old woman for female and a 46-year-old man for male participants. The video screen was adjusted in height such that it corresponded to the legs of the standing participant, with a mirror placed above it. Participants began the training session with a circa one minute of concentration on the upcoming intervention. Afterwards, the video was started. Participants were instructed to stand (when necessary, to sit) and observe the video and mirror, and to imagine themselves walking. Training sessions were supervised by a physical therapist who gave additional instructions and comments regarding participants' visual/kinesthetic imagination of themselves performing the observed movement. Verbal and physical reactions during training sessions were documented in written form and sometimes videotaped.

Virtual Gait Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • older than 65 years of age
  • fall within last 6 months

You may not qualify if:

  • cognitive deficits
  • physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mobility Center

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

  • Reto W Kressig, MD

    Dept. of Geriatrics, University Hospital Basel, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 30, 2012

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations