A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults (VTIME)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborators:
Newcastle University
University Medical Center Nijmegen
Universita degli Studi di Genova
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01732653
First received: November 5, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Condition Intervention
Elderly Adults
Parkinson
Mild Cognitive Disorder
Other: TT+VR
Other: TT alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Falls rate [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.


Secondary Outcome Measures:
  • Gait [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Participants will be asked to walk in a well-lit corridor under 3 conditions each of 1 minute: i) walking in a comfortable speed, ii) walking while subtracting 3s from a predefined number (dual task), iii) walking while negotiating two obstacles placed on the floor at specific locations. Spatial-temporal gait characteristics (e.g., gait speed (m/s), stride length (m), stride time (s), swing time (%), asymmetry, and step width (cm)) will be determined. Endurance will be assessed using the 2 Minute Walk Test.

  • Cognitive function [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, NeuroTrax Corp., NJ). In addition, we will also include standardized neuropsychological tests such as the Montreal Cognitive Assessment (MoCA); The Trail Making Test (TMT) and the Verbal Fluency test.

  • Balance and mobility [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    The Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest) will be used to assess mobility. Community ambulation will be assessed using The Physical Activity Scale for the Elderly (PASE) and a tri-axial accelerometer (Axivity Ltd.) which will be worn by the participants for 7 days to quantify and monitor stepping and physical activity.

  • Quality of life [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    The SF-36 Health Survey, a generic self-report questionnaire designed to address health related quality of life will be used. Fear of Falling will be evaluated using the Falls Efficacy Scale-International.


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TT+VR
The training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions).
Other: TT+VR
subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.
Other Name: training on a treadmill with virtual reality
Active Comparator: TT alone
The training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions).
Other: TT alone
The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
Other Name: treadmill training

Detailed Description:

A prospective, single blinded, parallel group, randomized controlled trial with 6 month follow-up will be employed to investigate the effects of treadmill training augmented with virtual reality on fall risk. The study will include 300 older participants who have experienced two or more falls in the previous 6 months. Participants will be randomized to either the intervention or control group. The intervention group will receive 18 sessions of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will receive 18 training sessions of treadmill training alone (TT) without the VR simulation All interventions will be delivered by therapists trained in the standard protocols. All subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45 minutes.Training progression will be based on increasing both motor and cognitive challenges, individualized to the participant's level of performance.

Primary outcome measures:

The primary outcome measure of the study is fall rate for 6 months post intervention. Secondary outcome measures will include gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Endurance will be assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days. Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests (Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will be evaluated using the SF-36 Health Survey

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 or more falls within 6 months prior to the beginning of the study
  • Aged 60-85 years
  • Able to walk for 5 minutes unassisted
  • Adequate hearing and vision capabilities.
  • Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

  • Psychiatric co-morbidity
  • Clinical diagnosis of dementia or other severe cognitive impairment (MMSE<24)
  • History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
  • Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
  • Unstable medical condition in the past 6 months
  • Unable to comply with the training
  • Interfering therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732653

Contacts
Contact: Anat Mirelman, PhD +972 3 6973960 anatmi@tasmc.health.gov.il

Locations
Belgium
Department of Rehabilitation Sciences, Katholieke Universiteit Leuven Not yet recruiting
Leuven, Belgium
Contact: Alice Nieuwboer, PhD       Alice.Nieuwboer@faber.kuleuven.be   
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Anat Mirelman, PhD    +972 3 6973960    anatmi@tasmc.health.gov.il   
Principal Investigator: Jeff M Hausdorff, PhD         
Italy
Department of Neurosciences Universita Degli Studi Di Genova, Italy Not yet recruiting
Genova, Italy
Contact: Elisa Pelosin, PhD       elisapelosin@yahoo.it   
Netherlands
Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands Not yet recruiting
Nijmegen, Netherlands
Contact: Miriam Reelick, PhD       M.Reelick@ger.umcn.nl   
United Kingdom
Institute for Aging and Health, University of Newcastle, UK Not yet recruiting
Newcastle, United Kingdom
Contact: Lynn Rochester, PhD       Lynn.rochester@newcastle.ac.uk   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Newcastle University
University Medical Center Nijmegen
Universita degli Studi di Genova
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Jeffrey M Hausdorff, PhD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01732653     History of Changes
Other Study ID Numbers: TASMC-12-NG-0505-CTIL, VTIME
Study First Received: November 5, 2012
Last Updated: November 19, 2012
Health Authority: Israel: Ethics Commission
United Kingdom: Research Ethics Committee
Belgium: Ethics Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee

Keywords provided by Tel-Aviv Sourasky Medical Center:
virtual reality,
falls,
elderly,
Parkinson's disease,
MCI

Additional relevant MeSH terms:
Cognition Disorders
Parkinson Disease
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 11, 2014