title: Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial.
abstract: BACKGROUND
  Enhancement of functional ambulation is a key goal of rehabilitation for children with cerebral palsy (CP) who experience gross motor impairment. Physiotherapy (PT) approaches often involve overground and treadmill-based gait training to promote motor learning, typically as free walking or with body-weight support. Robotic-assisted gait training (RAGT), using a device such as the Lokomat®Pro, may permit longer training duration, faster and more variable gait speeds, and support walking pattern guidance more than overground/treadmill training to further capitalize on motor learning principles. Single group pre-/post-test studies have demonstrated an association between RAGT and moderate to large improvements in gross motor skills, gait velocity and endurance. A single published randomized controlled trial (RCT) comparing RAGT to a PT-only intervention showed no difference in gait kinematics. However, gross motor function and walking endurance were not evaluated and conclusions were limited by a large PT group drop-out rate.
  
  
  METHODS
  In this two-group cross-over RCT, children are randomly allocated to the RAGT or PT arm (each with twice weekly sessions for eight weeks), with cross-over to the other intervention arm following a six-week break. Both interventions are grounded in motor learning principles with incorporation of individualized mobility-based goals. Sessions are fully operationalized through manualized, menu-based protocols and post-session documentation to enhance internal and external validity. Assessments occur pre/post each intervention arm (four time points total) by an independent assessor. The co-primary outcomes are gross motor functional ability (Gross Motor Function Measure (GMFM-66) and 6-minute walk test), with secondary outcome measures assessing: (a) individualized goals; (b) gait variables and daily walking amounts; and (c) functional abilities, participation and quality of life. Investigators and statisticians are blinded to study group allocation in the analyses, and assessors are blinded to treatment group. The primary analysis will be the pre- to post-test differences (change scores) of the GMFM-66 and 6MWT between RAGT and PT groups.
  
  
  CONCLUSIONS
  This study is the first RCT comparing RAGT to an active gait-related PT intervention in paediatric CP that addresses gait-related gross motor, participation and individualized outcomes, and as such, is expected to provide comprehensive information as to the potential role of RAGT in clinical practice.Trial registrationClinicalTrials.gov NCT02196298.
authors.affiliation: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd, Toronto, ON M4G 1R8 Canada ; Rehabilitation Sciences Institute, Faculty of Medicine, University of Toronto, Toronto, ON Canada.
authors.forename: Alicia J
authors.initials: AJ
authors.lastname: Hilderley
authors.affiliation: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd, Toronto, ON M4G 1R8 Canada ; Rehabilitation Sciences Institute, Faculty of Medicine, University of Toronto, Toronto, ON Canada ; Department of Paediatrics, Faculty of Medicine, University of Toronto, Toronto, ON Canada.
authors.forename: Darcy
authors.initials: D
authors.lastname: Fehlings
authors.affiliation: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd, Toronto, ON M4G 1R8 Canada.
authors.forename: Gloria W
authors.initials: GW
authors.lastname: Lee
authors.affiliation: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd, Toronto, ON M4G 1R8 Canada ; Rehabilitation Sciences Institute, Faculty of Medicine, University of Toronto, Toronto, ON Canada ; Department of Physical Therapy, University of Toronto, Faculty of Medicine, Toronto, ON Canada.
authors.forename: F Virginia
authors.initials: FV
authors.lastname: Wright
keywords: Cerebral palsy; Gait; Orthotic devices; Physical therapy modalities; Robotics