Hollands 2012

Trial name or title	Visual cues for gait training post stroke
Methods	Method: RCT, parallel assignment Method of randomisation: not described Blinding of outcome assessors: yes ITT: unclear
Participants	Country: Australia Target sample size: 60 people with stroke Ambulatory at study onset: yes Inclusion criteria: diagnosis of stroke; being able to walk 10 metres with or without assistance; residual paresis in the lower limb (Fugl‐Meyer lower limb score less than 34), informed written consent Exclusion criteria: gait speed more than 0.8 m/s; patients with a premorbid (retrospective) modified Rankin Scale score of greater than 3; gait deficits attributable to non‐stroke pathology; visual impairments preventing use of visual cue training (as assessed by Apple Cancellation test), concurrent progressive neurologic disorder, acute coronary syndrome, severe heart failure, confirmed or suspected lower‐limb fracture preventing mobilisation, those requiring palliative care, inability to follow a 3‐step command (as assessed by Modified MMSE)
Interventions	3 arms: Active comparator: usual care group will receive task‐specific overground walking rehabilitation for 8 weeks, 2 times per week (120 minutes per week) EXP: overground visual cue training group will receive overground walking rehabilitation with visual cues for 8 weeks, 2 times per week (120 minutes per week) EXP: treadmill visual cue training group will receive treadmill training with visual cues for 8 weeks, 2 times per week (120 minutes per week)
Outcomes	Outcomes will be assessed at baseline, at the end of the intervention phase and at 3‐month follow‐up: Primary outcome: participant enrolment, recruitment and retention Secondary outcomes: 180 degree turn (time taken (s) and number of steps (#) to complete a 180 degree turn) gait adaptability (the number of times participants fail to hit stepping targets when these are presented unpredictably in timing and location will be used to indicate the ability to adapt the straight gait pattern according to environmental demands) Timed Up and Go (TUG) test (7 metres) Fugl‐Meyer Lower Limb Motor Assessment Berg Balance Scale Falls Efficacy Scale health‐related quality of life (SF‐12) FAC gait speed (10‐metre walk)
Starting date	May 2012
Contact information	Trudy A Pelton, MRes Email: t.a.pelton@bham.ac.uk Kristen Hollands, PhD Email: k.hollands@salford.ac.uk
Notes