NCT00284115

Trial name or title	Efficacy of a mechanical gait repetitive training technique compared with a usual rehabilitation program on gait recovery in hemiparetic stroke patients
Methods	RCT with 2 arms
Participants	Country: France Inclusion criteria: men or women aged 18 years or older; hemiplegia secondary to stroke; interval between stroke and study inclusion of 2 months or less; first‐time supratentorial stroke; non‐ambulatory patient (FAC Stage 0); able to sit unsupported at the edge of the bed; no severe impairment of cognition or communication; written informed consent provided Exclusion criteria: orthopaedic or rheumatological disease impairing mobility, or both; other neurologically associated disease; history of myocardial infarction or deep venous embolism or pulmonary embolism within 3 months before study inclusion; chronic pulmonary disease; intolerance to standing up
Interventions	4‐Week rehabilitation programme associating physiotherapy and gait trainer therapy or physiotherapy alone
Outcomes	Primary outcomes: walking speed (time needed to walk 10 metres) after the 4‐week rehabilitation programme Secondary outcomes: FAC; walking endurance (6‐minute walk); time to self‐sufficient gait recovery; spasticity (modified Ashworth score); Motricity Index; need for mobility and self‐assistance (Barthel score, PMSI‐SSR scores, need for physical assistance); economic evaluation (healthcare requirements, rehabilitation unit length of stay)
Starting date	March 2006
Contact information	Principal investigator: Régine Brissot, MD, Service de Médecine Physique et Réadaptation, Hôpital Pontchaillou, Rennes, 35033, France Tel: +33 2 9928 4219 email: regine.brissot@chu‐rennes.fr
Notes	Expected total enrolment: 122 participants Sponsored by: Rennes University Hospital Information derived from: ClinicalTrials.gov Identifier: NCT00284115