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

Elderly Clinical Trial

— VR-Fallers  

Official title:

Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01182961
• Other study ID #: TASMC-10-NG-0113-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2010
• Last updated: August 27, 2010
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Anat Mirelman, PhD
• Phone: +972 3 6974958
• Email: anatmi[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly

Intervention

Other:
• gait training
subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device
• gait training 2
subjects will walk on a treadmill under a progressive intensive gait protocol
• exercise group
standard of care exercise group to improve strength and balance

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait dynamics	using an accelerometer, the coefficient of variation will be calculated	one week after training	No
Secondary	cognitive function	using a cmputerized cognitive battary and neuropsychological testing	one week after training	No