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

Parkinson Clinical Trial

— VTIME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732653
• Other study ID #: TASMC-12-NG-0505-CTIL
• Secondary ID: VTIME
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: April 17, 2016
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionUnited Kingdom: Research Ethics CommitteeBelgium: Ethics CommitteeItaly: Ethics CommitteeNetherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cognition Disorders
• Elderly Adults
• Mild Cognitive Disorder
• Mild Cognitive Impairment
• Parkinson
• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Department of Rehabilitation Sciences, Katholieke Universiteit Leuven	Leuven
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Department of Neurosciences Universita Degli Studi Di Genova, Italy	Genova
Netherlands	Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands	Nijmegen
United Kingdom	Institute for Aging and Health, University of Newcastle, UK	Newcastle

Sponsors (5)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Katholieke Universiteit Leuven, Newcastle University, Universita degli Studi di Genova, University Medical Center Nijmegen

Countries where clinical trial is conducted

Belgium,  Israel,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls rate	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.	6 months post intervention	No
Secondary	Gait	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.	6 months post intervention	No
Secondary	Cognitive function	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.	6 months post intervention	No
Secondary	Balance and mobility	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.	6 months post intervention	No
Secondary	Quality of life	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.	6 months post intervention	No