Trial name or title | Very Intensive Early Walking in Stroke (VIEWS) |
Methods | Method: RCT, parallel assignment Method of randomisation: not described Blinding of outcome assessors: yes ITT: unclear |
Participants | Country: USA 56 people with chronic stroke Ambulatory at study onset: yes Inclusion criteria: subacute (< 6 months) stroke; 18 to 75 years old; history of unilateral, supratentorial, ischaemic or haemorrhagic stroke; being able to walk 10 metres without physical assistance; gait speed less than or equal to 0.8 m/s; medical clearance Exclusion criteria: significant cardiorespiratory or metabolic disease that may limit exercise participation; weight limit > 113 kg; history of previous orthopaedic or neurological conditions which may impair walking; MMSE < 23 Exclusion for transcranial magnetic stimulation (TMS): pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, pregnancy Exclusion for the MRI: aneurysm clip or coil, metal or wire implants, heart valve prosthesis |
Interventions | 2 arms:
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Outcomes | Primary outcomes will be assessed at baseline, at the end of the intervention phase at 8 weeks and at 3‐month follow‐up:
Secondary outcomes will be assessed at baseline, at the end of the intervention phase at 8 weeks and at 2‐month follow‐up:
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Starting date | October 2008 |
Contact information | Carey Holleran, MPT, NCS Email: cholleran@ric.org Abigal Leddy, PT, DPT Email: aleddy@ric.org |
Notes |