Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial
1 Research Fellow School of Health Sciences, University of Salford, Allerton Building, Salford M6 6PU, UK
2 Colleges of Life and Environmental Sciences & Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK
3 Birmingham Community Health Care NHS Trust, (BCHCT), Moseley Hall Hospital, Birmingham B13 8JL, UK
4 University of Nottingham, Nottingham Clinical Trials Unit, Nottingham Health Science Partners, C-floor, South Block, Queen’s Medical Centre, Nottingham NG7 2UH, UK
5 University of East Anglia, School of Allied Health Professions, Queens Building, Earlham Road, Norwich, Norfolk NR4 7TJ, UK
6 University of Newcastle, School of Health Sciences, Newcastle, Hunter Building Callaghan, University Drive, Callaghan, NSW 2308, Australia
Trials 2013, 14:276 doi:10.1186/1745-6215-14-276Published: 3 September 2013
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. 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.
A 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.
Participation 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.