Hemiplegia, Stroke
Conditions
Keywords
Gait trainer, Hemiplegia, Rehabilitation, Stroke
Brief summary
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.
Detailed description
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone. The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.
Interventions
DEVICEGait trainer
Mechanical gait repetitive training
DEVICEConventional rehabilitation
Physiotherapeutic conventional rehabilitation
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18 years or more * Hemiplegia secondary to stroke * Interval between stroke and study inclusion of 4 month or less * First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke * Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1) * Being able to sit unsupported at the edge of the bed * No severe impairment of cognition or communication * Written informed consent
Exclusion criteria
* Orthopedic and/or rheumatological disease impairing mobility * Other Neurological associated disease * History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion * Chronic pulmonary disease * Intolerance to stand up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program | after 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking endurance (6 minute walk) | days 15, 28 and 90. | distance covered in a 6 minutes confortable walk |
| Time to self sufficient gait recovery | Since inclusion Time | — |
| Spasticity (modified Ashworth score) | Days 0, 15, 28 and 90 | — |
| Functional ambulatory category | Days 0, 15, 28 and 90. | — |
| Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance) | Days 0, 15, 28 and 90 | — |
| Economic evaluation (healthcare requirements, rehabilitation unit length of stay) | At the end of the study | — |
| Motricity index | Days 0, 15, 28 and 90 | — |
Countries
France
Outcome results
None listed