New Technology for Individualised, Intensive Training of Gait After Stroke- Study II "HAL-RCT-II"

Recruiting

Phase 3 Results N/A

Update History

1 Oct '15
The description was updated.
New
The primary aim of the study is to compare the effectiveness of: - intensive training with HAL, - intensive training without HAL and - standard training, in a later phase (1-10 years) after stroke on independence in ambulation after intervention by comparing the Functional Ambulation Category in each group. Secondary aims comprise the effectiveness of training with HAL on independence gait function and quality, cardiovascular function, activity of daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up. Effects on health care consumption during 12 months after the intervention will be explored and treatment related adverse events during the study will be documented. Further, associations between range of movement, strength and spasticity versus HAL mediated recovery will also be explored. Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living. The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. The 2nd control group will not receive an intervention. The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living
Old
The primary aim of the study is to compare the effectiveness of: - intensive training with HAL, - intensive training without HAL and - standard training, in a later phase (1-10 years) after stroke on independence in ambulation after intervention by comparing the Functional Ambulation Category in each group. Secondary aims comprise the effectiveness of training with HAL on independence gait function and quality, cardiovascular function, activity of daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up. Effects on health care consumption during 12 months after the intervention will be explored and treatment related adverse events during the study will be documented. Further, associations between range of movement, strength and spasticity versus HAL mediated recovery will also be explored. Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living. The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. The 2nd control group will not receive an intervention. The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living
A location was updated in Danderyd.
New
The overall status was updated to "Recruiting" at Department of Rehabilitation Medicine, Danderyd Hospital.