Abstract
BackgroundVisual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize, therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait training with visual cues in contrast to conventional overground walking practice following stroke.Methods/designA 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants (n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment, delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants.Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included.The primary outcomes concerning participant enrolment, recruitment, retention, and health and social care resource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months (follow-up). Outcome measures will include gait speed and step length symmetry; time and steps taken to complete a 180° turn; assessment of gait adaptability (success rate in target stepping); timed up and go; Fugl-Meyer lower limb motor assessment; Berg balance scale; falls efficacy scale; SF-12; and functional ambulation category.DiscussionParticipation and compliance measured by treatment logs, accrual rate, attrition, and response variation will determine sample sizes for an early phase randomised controlled trial and indicate whether a definitive late phase efficacy trial is justified.Trial registrationClinicaltrials.gov, NCT01600391.
Highlights
Visual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke
Usual care The purposes of the usual care (UC) group are to provide (1) a taskspecific-based intervention that does not include use of visual cues designed to influence quality or adaptability of gait; (2) an equal number of interactions and time spent with a physical therapist to minimize any potential for bias due to differential exposure and minimize the risk for differential loss to follow-up; and (3) a credible training program so that the participants would consider themselves involved in meaningful therapy activity
Recovery of independent mobility after stroke is a major priority of rehabilitation but evidence indicates that current approaches have only modest effects on walking impairment and activity [6,7]
Summary
Recovery of independent mobility after stroke is a major priority of rehabilitation but evidence indicates that current approaches have only modest effects on walking impairment and activity [6,7]. Authors’ contribution KH conceptualized the study, contributed to the design and the procurement of funding, developed procedures for implementing the protocol, oversees coordination of the trial and helped draft the manuscript. PvV conceptualized the study, contributed to the design and the procurement of funding and developed procedures for implementing the protocol. CS contributed to the design and the procurement of funding and developed procedures for implementing the protocol. AWing contributed to the design and the procurement of funding and developed procedures for implementing the protocol. AWimperis contributed to the design and the procurement of funding and developed procedures for implementing the protocol. TP developed procedures for implementing the protocol, conducted all blinded assessments, participated in the coordination of the trial and helped to draft the manuscript.
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