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

Recruiting

Phase N/A Results N/A

Update History

6 Apr '18
The Summary of Purpose was updated.
New
The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke. The main specific aims are: (i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention.
Old
The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke. The main specific aims are: (i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention. (ii) to estimate health care utilization during the first year after the intervention and the cost effectiveness of having trained with the HAL.
The description was updated.
New
The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up. 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 effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in 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
19 Jan '18
The Summary of Purpose was updated.
New
The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke. The main specific aims are: (i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention. (ii) to estimate health care utilization during the first year after the intervention and the cost effectiveness of having trained with the HAL.
Old
The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke. The main specific aims are - to demonstrate the effect of intensive training with HAL in comparison with intensive training without HAL and with standard care only, in a later phase (1-10 years) after stroke with regard to gait and cardio-vascular function, activity and participation; - to estimate health care utilisation and cost effectiveness of using the HAL during the first year after stroke.
The description was updated.
New
The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in 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
Trial was updated to "N/A."
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - 1-10 years since stroke onset - Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed <0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008) - Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy - Body size compatible with the HAL suit. Exclusion Criteria: - Contracture restricting gait movements at any lower limb joint - Cardiovascular or other somatic condition incompatible with intensive gait training - Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).
Old
Inclusion Criteria: - 1-10 years since stroke onset - Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed <0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008) - Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy - Body size compatible with the HAL suit. Exclusion Criteria: - Contracture restricting gait movements at any lower limb joint - Cardiovascular or other somatic condition incompatible with intensive gait training - Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).
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.