Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study
Condition: Stroke; Paresis; Gait, Hemiplegic
MeSH terms: Stroke; Paresis; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Phase II: Investigating the effects of additional robot-assisted gait training either
      initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.
    

Detailed description: 
      GENERAL:

      Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy
      early after stroke. For example, training has led to substantial recovery if initiated 5 or
      14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this
      early period is characterized by heightened levels of plasticity and that training can
      exploit this leading to improved outcome. The typically observed non-linear recovery pattern
      in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the
      human brain, however clinical research on this is disappointingly sparse.

      In two closely inter-related phases, we aim to examine the biomechanical changes related to
      walking recovery in general (Phase I) and the specific effects of robot-assisted training
      (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the
      same characteristics as observed in animal models. To initiate gait training at an early
      stage, when patients usually present severe weakness and balance deficits, a mobile
      exoskeleton is used which is developed to provide intensive walking practice.

      OBJECTIVES:

      (II.a) Are stroke survivors who train with the assistance of a robot at an early stage more
      likely to achieve independent walking?

      (II.b) Does additional robot-assisted training modulate the recovery of standing and walking
      ability by enhancing behavioral restitution?
    

Intervention name(s): Exoskeleton-assisted gait training
Intervention type(s): Behavioral
Intervention description(s): In the experimental groups, participants are provided with 1-hour sessions of gait training with robot assistance, 4 times per week for 4 weeks. Assistance is provided by the Ekso GT (Ekso Bionics, Richmond, CA, USA), an exoskeleton consisting of fitted metal braces that supports the legs, feet, and trunk of the patient. Powered motors drive knee and hip joints in the sagittal plane to assist during standing up and walking over level surfaces. Steps are initiated if an active weight-shift towards the stance leg is performed by the patient. The provided assistance in stance and swing is adaptable to the patient's ability and can be adjusted for each leg separately.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to either the "early group" or "delayed group". Both groups will be provided a dose- and content-controlled intervention in addition to usual care. The early group will receive this intervention at approximately 2 weeks post-stroke and the delayed group at 8 weeks post-stroke. As such, this study is explicitly designed to investigate the effects of time to initiate rehabilitation on recovery outcomes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; rehabilitation; robotics