Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation
Condition: Transtibial Amputation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and
      mobility rehabilitation in individuals with transtibial amputation. The system is composed of
      a treadmill that can simulate different environmental situations such as walking up stairs
      and hills and going around curves. The treadmill is synchronized with an immersive display
      and an avatar of the user. The combination of variable terrain and visual feedback is
      extremely promising as a means for amputee patients to achieve improved functional mobility
      after gait training. The proposed work is relevant to public health because it is the first
      step in developing a novel rehabilitation system that will use visual feedback for gait
      training in amputees and others with pathological gait disorders. The research is pertinent
      to the mission of the Department of Veterans Affairs which is committed to improve the
      quality of life of Veterans with disability.
    

Detailed description: 
      Lower extremity amputation can cause impairments in gait and balance due to the loss of
      proprioception and motor control. The asymmetries present during amputee gait are thought to
      be one of the major contributors to secondary musculoskeletal problems such as
      osteoarthritis. After lower extremity amputation, physical rehabilitation is necessary to
      achieve functional ambulation; however, no an evidence-based standard of care exists for
      individuals who undergo transtibial (TT) amputations. The objective of this application is to
      determine the effectiveness of gait training in an immersive virtual environment in people
      with transtibial amputation. The investigators' custom designed Virtual Gait Retraining
      System (VGRS) is a virtual reality (VR) system which provides visual and motor challenges
      while treadmill walking. The VGRS immerses the user in a virtual world, provides additional
      feedback with an avatar and presents the user with challenging tasks such as inclines and
      stair climbing which are complemented by the movement of the treadmill. The central
      hypothesis is that people with amputations will achieve greater improvements in balance,
      mobility and gait function using the investigators' custom designed VGRS as compared to
      current conventional treadmill gait training. This objective will be accomplished by
      addressing the following specific aims:

        -  1) Compare the efficacy of VGRS to conventional treadmill training.

        -  2) Evaluate the rate of improvement over the course of each training program (VGRS and
           conventional treadmill).

      The investigators will conduct a randomized clinical trial with twenty TT amputee subjects
      comparing 6 weeks of training with the VGRS to 6 weeks of training using a conventional
      treadmill protocol. The investigators will use gait analysis, postural sway and standard
      balance and mobility instruments including the 6-Minute Walk Test, Four Square Step Test, the
      Berg Balance Scale and the Dynamic Gait Index to assess improvements in gait and mobility.
      The investigators will evaluate subject pre- and post training and at an interim point 3
      weeks into the training sessions. The investigators anticipate that the VGRS will deliver
      more effective training by creating a realistic and challenging environment with accurate
      visual perception of a motor task which is being simultaneously performed by the user. The
      investigators will also gain an understanding of the rate of improvement for TT amputees
      during treadmill training. The research design will demonstrate the need for immersive
      virtual reality that includes a rich visual display and affords the opportunity to train on a
      variety of terrain conditions and mobility tasks.
    

Intervention name(s): Virtual Reality Gait Training; Treadmill Gait Training
Intervention type(s): Other; Other
Intervention description(s): A Virtual Gait Retraining System (VGRS) will be used to train amputees for six weeks. the system consists of an actuated treadmill, a virtual environment and an avatar; A conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gait; Rehabilitation; Virtual Reality