Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, 18288, Sweden
NCT Number: NCT02545088
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Danderyd, Stockholm County, 18288, Sweden
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intensive gait training with Hybrid Assistive Limb (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.
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.
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
walking ability and endurance
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Sensory and motor function in lower extremities
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Balance
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Walking
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Walking
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Walking
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Interview
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Interview
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Independence in mobility and personal care
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Functioning and disability, Interview
Time frame: Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention
Registers physical activity in everyday life
Time frame: Assessment at baseline
Stroke severity
Time frame: Assessment at baseline
Interview
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Registered in everyday life
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Blood test
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Blood test
Time frame: after 6 weeks of intervention
Interview. Study group using Hybrid Assistive Limb (HAL) only.
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Interview
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Interview
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
From medical records
Time frame: 12 month post intervention
From County Council
Time frame: At baseline
From medical records
Time frame: At baseline
Filled in by significant other
Danderyd Hospital
Other
New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study II
Acronym: HAL-RCT-II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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