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| Name | Class |
|---|---|
| University of Tsukuba | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Umeå University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group Hybrid Assistive Limb (HAL) | Experimental |
| |
| 1st control group | Active Comparator |
| |
| 2nd control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Assistive Limb (HAL) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 min walk test | walking ability and endurance | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Scale for lower extremities | Sensory and motor function in lower extremities | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Modified Ashworth Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Danderyd Hospital | Danderyd | Stockholm County | 18288 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24890413 | Background | Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92. | |
| 25859191 | Background | Wall A, Borg J, Palmcrantz S. Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review. Front Syst Neurosci. 2015 Mar 25;9:48. doi: 10.3389/fnsys.2015.00048. eCollection 2015. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D051346 | Mobility Limitation |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 1st control group | Other | Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. |
|
| 2nd control group | Other | The 2nd control group will not receive an intervention. |
|
Spasticity
| Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Spasticity measured with Neuroflexor foot module | Spasticity | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Berg Balance Scale | Balance | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| 10 meters walk test | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| 2 minutes walk test | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Functional Ambulation Categories | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Borg Rating of Perceived Exertion Scale (RPE) | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Montreal Cognitive Assessment | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Hospital anxiety and Depression Scale | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Barthel Index | Independence in mobility and personal care | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Stroke Impact Scale | Functioning and disability, Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Physical activity in everyday life using SenseWear | Registers physical activity in everyday life | Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention |
| Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) | Stroke severity | Assessment at baseline |
| Modified Ranking Scale | Interview | Assessment at baseline |
| Body Mass Index | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Weight | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Height | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Blood pressure | Registered in everyday life | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| HbA1c | Blood test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Plasma lipid profile | Blood test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Perception of the intervention | Interview. Study group using Hybrid Assistive Limb (HAL) only. | after 6 weeks of intervention |
| Smoking | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Alcohol | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Drug use | From medical records | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
| Health care consumption | From County Council | 12 month post intervention |
| Stroke type and localization | From medical records | At baseline |
| Dysexecutive Questionnaire | Filled in by significant other | At baseline |
| 36893079 | Derived | Bergqvist M, Moller MC, Bjorklund M, Borg J, Palmcrantz S. The impact of visuospatial and executive function on activity performance and outcome after robotic or conventional gait training, long-term after stroke-as part of a randomized controlled trial. PLoS One. 2023 Mar 9;18(3):e0281212. doi: 10.1371/journal.pone.0281212. eCollection 2023. |
| 33967683 | Derived | Palmcrantz S, Wall A, Vreede KS, Lindberg P, Danielsson A, Sunnerhagen KS, Hager CK, Borg J. Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke-A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up. Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |