The Use of Virtual Reality for the Gait Training of Elderly Fallers

NCT ID: NCT01182961

Last Updated: 2010-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.

Conditions

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Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treadmill +virtual reality training

Group Type EXPERIMENTAL

gait training

Intervention Type OTHER

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

Treadmill alone

Group Type ACTIVE_COMPARATOR

gait training 2

Intervention Type OTHER

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

standard of care exercise group

Group Type ACTIVE_COMPARATOR

exercise group

Intervention Type OTHER

standard of care exercise group to improve strength and balance

Interventions

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gait training

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

Intervention Type OTHER

gait training 2

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

Intervention Type OTHER

exercise group

standard of care exercise group to improve strength and balance

Intervention Type OTHER

Other Intervention Names

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virtual reality treadmill

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv University

Principal Investigators

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Nir Giladi, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Anat Mirelman, PhD

Role: CONTACT

+972 3 6974958

Facility Contacts

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Anat Mirelman, PhD

Role: primary

+972 3 6974958

Other Identifiers

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TASMC-10-NG-0113-CTIL

Identifier Type: -

Identifier Source: org_study_id

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