A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults
Condition: Elderly Adults; Parkinson; Mild Cognitive Disorder
MeSH terms: Parkinson Disease; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional

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.
    

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
    

Intervention name(s): TT+VR; TT alone
Intervention type(s): Other; Other
Intervention description(s): 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.; 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 intervention name(s): training on a treadmill with virtual reality; treadmill training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: virtual reality,; falls,; elderly,; Parkinson's disease,; MCI