Giraux 2008.
Methods | Design: multi‐centre RCT |
Participants | Estimated enrolment: n = 240 Inclusion criteria: "(1) Patients must be aged between 18 to 75 years, with a first ischemic or hemorrhagic stroke at least six months ago and no longer than two years ago, without a subsequent stroke. It must have caused initially complete hemiplegia of the right or left hemibody, but they must be able [to] walk alone with or without technical assistance over a distance of at least 10m. They must be able to change direction too and (2) They must have a functional ambulation classification score between 4 and 6 during the inclusion" Exclusion criteria: "(1) We will exclude patients with a neurological history other than a stroke, a psychiatric illness, or an associated debilitating disease, (2) They must not have an associated cerebella syndrome or a clinical brainstem attack and (3) We will refuse patients who are pregnant, who have not signed the written consent and who aren't entitled to a social security scheme" |
Interventions | "(1) Active comparator: patients who continue physical therapy sessions during two months. Intervention: behavioural—two physical therapy sessions per week for two months" "(2) No intervention: patients who stop physical therapy sessions during two months. Intervention: behavioural—patients who stop two physical therapy sessions per week for two months" |
Outcomes | Primary outcome measures: average number of steps/d recorded over three days in an outpatient setting. To be measured at day three and then six months later Secondary outcome measures: Six‐Minute Walking test, Wade's test, Rivermead Mobility Index score and Barthel Index. These will be measured at day zero and at day 55 |
Notes | Clarification of intervention sought but not obtained |