Forrester 2011

Trial name or title	Ankle robotics training after stroke: effects on gait and balance
Methods	RCT with 3 arms
Participants	Inclusion criteria: ischaemic or haemorrhagic stroke > 6 months prior in men or women aged 18 to 80 years, clear indications of hemiparetic gait by clinical observation, completed all conventional physical therapy, ability to walk on a treadmill with handrail support Exclusion criteria: cardiac history of (1) unstable angina, (2) recent (< 3 months) myocardial infarction, congestive heart failure (NYHA category II), (3) haemodynamically significant valvular dysfunction; major clinical depression: CES‐D score > 16 and judgment of clinical depression; medical history: (1) recent hospitalisation (< 3 months) for severe medical disease, (2) symptomatic peripheral arterial occlusive disease, (3) orthopaedic or chronic pain conditions that significantly alter gait function, (4) pulmonary or renal failure, (5) active cancer; history of non‐stroke neuromuscular disorder restricting gait; aphasia or cognitive functioning that confounds participation, defined as unable to follow 2‐step commands; the MMSE will be administered with a cut‐off of < 23 (< 17 if education level at or below 8th grade) or judgement of the medical officer; hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on 2 assessments); self report of pregnancy
Interventions	EXP Arm 1: seated robot training group: participants at least 6 months post stroke will use the ankle robot in a seated visuo‐motor training paradigm; they will train on the robot 3 times per week for 6 weeks (18 sessions) by playing video games with the paretic ankle; they will be evaluated on outcomes at baseline, post 6 weeks training and again after a 6‐week retention period with no training EXP Arm 2: treadmill training with ankle robot group: participants at least 6 months post stroke will wear the ankle robot during treadmill locomotor training; they will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions); they will be evaluated on outcomes at baseline, post‐6 weeks training and again after a 6‐week retention period with no training Active comparator: Arm 3: treadmill‐only group: this group will consist of participants at least 6 months post stroke who engage in treadmill training 3 x weekly for 6 weeks without robotic support; they will be volunteers from another treadmill training study and will be evaluated on outcomes at baseline and post 6 weeks training; they will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6‐week period
Outcomes	Primary outcomes: self selected floor walking velocity, velocity and associated spatio‐temporal gait parameters from self selected; most comfortable and fastest floor walking over 10 metres Secondary outcomes: gait kinetics, anterior‐posterior and medio‐lateral ground reaction forces during walking to assess propulsive impulses from paretic and non‐paretic sides, Berg Balance Scale, Dynamic Gait Index, Anticipatory Postural Adjustments
Starting date	July 2011
Contact information	Contact: Larry Forrester, PhD Email: Larry.Forrester@va.gov
Notes	Estimated primary completion date: March 2013 (final data collection date for primary outcome measure)