NCT01182961

Brief Summary

The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 20, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 30, 2010

Status Verified

August 1, 2010

Enrollment Period

2 years

First QC Date

July 20, 2010

Last Update Submit

August 27, 2010

Conditions

Keywords

GaitFallsVirtual reality

Outcome Measures

Primary Outcomes (1)

  • Gait dynamics

    using an accelerometer, the coefficient of variation will be calculated

    one week after training

Secondary Outcomes (1)

  • cognitive function

    one week after training

Study Arms (3)

Treadmill +virtual reality training

EXPERIMENTAL
Other: gait training

Treadmill alone

ACTIVE COMPARATOR
Other: gait training 2

standard of care exercise group

ACTIVE COMPARATOR
Other: exercise group

Interventions

subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device

Also known as: virtual reality
Treadmill +virtual reality training

subjects will walk on a treadmill under a progressive intensive gait protocol

Also known as: treadmill
Treadmill alone

standard of care exercise group to improve strength and balance

standard of care exercise group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • between the ages of 65-85
  • independent in activities of daily living
  • able to walk without assistance for at least 10 minutes
  • cognitively intact (Mini Mental State Exam ≥24)
  • reported 2 or more falls within 6 months prior to the beginning of the study

You may not qualify if:

  • any neurological, orthopedic or any other impairment likely to impact gait.
  • severe visual impairments
  • major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Nir Giladi, MD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 20, 2010

First Posted

August 17, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

April 1, 2013

Last Updated

August 30, 2010

Record last verified: 2010-08

Locations