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| Name | Class |
|---|---|
| University of Tsukuba | OTHER |
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Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.
To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke.
Study design: Randomized, controlled study with blinded outcome assessment.
Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Intervention: Hybrid Assistive Limb (HAL); gait training in combination with conventional training. Training with the exosceleton Hybrid Assistive Limb (HAL) is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method. |
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| Control Group | Active Comparator | Intervention: Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Assistive Limb (HAL); gait training | Device | Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Ambulation Categories (FAC) | Level of independence in walking, range 0-5 | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Deviation Index (GDI) | Gait pattern function will be assessed using a motion capture system (Vicon MX40, Oxford, UK) with two force plates (Kistler, Winterthur, Switzerland) and wireless surface electromyography (EMG, Noraxon, Scottsdale, Arizona, USA). Markers will be placed according to a conventional full-body model (Vicon Plug-in-Gait) and surface EMGs, according to standardized electrode placement (www.seniam.org). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörgen Borg, Professor | Department of Rehabilitation medicine, Danderyd Hospital, Karolinska Institute | Principal Investigator |
| 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. | |
| 37885482 | Derived | Wall A, Palmcrantz S, Borg J, Gutierrez-Farewik EM. Gait pattern after electromechanically-assisted gait training with the Hybrid Assistive Limb and conventional gait training in sub-acute stroke rehabilitation-A subsample from a randomized controlled trial. Front Neurol. 2023 Oct 11;14:1244287. doi: 10.3389/fneur.2023.1244287. eCollection 2023. |
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| Control Group; Conventional gait training | Other | Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups. |
|
| After 4 weeks of training and 6 months after stroke |
| Change in GDI-kinetic. | Gait pattern function will be assessed using a motion capture system (Vicon MX40, Oxford, UK) with two force plates (Kistler, Winterthur, Switzerland) and wireless surface electromyography (EMG, Noraxon, Scottsdale, Arizona, USA). Markers will be placed according to a conventional full-body model (Vicon Plug-in-Gait) and surface EMGs, according to standardized electrode placement (www.seniam.org). | After 4 weeks of training and 6 months after stroke |
| Change in Barthel Index | Independence in mobility and personal care | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in Fugl-Meyer for Lower extremities | Sensory and motor function in lower extremities | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in Berg Balance scale | Balance | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in Modified Aschworth scale | Spasticity | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in 2 minutes walk test | Walking | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in Alberts test | Neglect | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Change in EQ5D | Health outcome | Assessed at baseline, after 4 weeks of training and 6 months after stroke |
| Stroke impact scale | Functioning and disability | 6 months after stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| D051346 | Mobility Limitation |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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