Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Detailed Description

Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.
Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.

Conditions

Interventions

  • Virtual reality (VR) system (CAREN Integrated Reality System)Other
    Intervention Desc: Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.
  • Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). Device
    Intervention Desc: Training 2/w for 9 weeks (total 18 sessions).
    ARM 1: Kind: Experimental
    Label: A,
    Description: Virtual Reality training for an overall of 18 sessions 2/week + usual care.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Community ambulation using Step Activity Monitor (SAM), Gait analysis (GaitRite system) including dual task, Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform, Timed Up and Go, Functional Reach, Four Stick Stepping Test (FSST), 3DGait Analysis system, 6 minute walk and self-induced perturbations and reaction to perturbations on platform completed at baseline X2, post training (week 9-10), retention (week 20-24). Virtual Reality training for an overall of 18 sessions 2/week + usual care for those in the experimental arm vs usual care for those in the control arm.

Outcomes

Type Measure Time Frame Safety Issue
Primary Community ambulation using Step Activity Monitor (SAM), Gait analysis (GaitRite system) including dual task, Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform, and Timed Up and Go completed at baseline X2, post training (week 9-10), retention (week 20-24).
Secondary Functional Reach, Four Stick Stepping Test (FSST), 3DGait Analysis system, 6 minute walk and self-induced perturbations and reaction to perturbations on platform completed at baseline X2, post training (week 9-10), retention (week 20-24).
Primary Community ambulation using Step Activity Monitor (SAM) Baseline X2, post training (week 9-10), retention (week 20-24) No
Primary Gait analysis (GaitRite system) including dual task Baseline X2, post training (week 9-10), retention (week 20-24) No
Primary Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform. Baseline X2, post training (week 9-10), retention (week 20-24) No
Primary Timed Up and Go Baseline X2, post training (week 9-10), retention (week 20-24) No
Secondary Functional Reach Baseline X2, post training (week 9-10), retention (week 20-24) No
Secondary Four Stick Stepping Test (FSST) Baseline X2, post training (week 9-10), retention (week 20-24) No
Secondary 3DGait Analysis system Baseline X2, post training (week 9-10), retention (week 20-24) No
Secondary 6 minute walk Baseline X2, post training (week 9-10), retention (week 20-24) No
Secondary Self-induced perturbations and reaction to perturbations on platform Baseline X2, post training (week 9-10), retention (week 20-24) No

Sponsors