Ambulation Difficulty, Gait, Hemiplegic, Hemiparesis, Stroke
Conditions
Keywords
Rehabilitation, Robotics
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHybrid Assistive Limb (HAL); gait training
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.
OTHERControl Group; Conventional gait training
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.
Sponsors
University of Tsukuba
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; 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; and severe, contagious infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Ambulation Categories (FAC) | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Level of independence in walking, range 0-5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in GDI-kinetic. | After 4 weeks of training and 6 months after stroke | 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). |
| Change in Barthel Index | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Independence in mobility and personal care |
| Change in Fugl-Meyer for Lower extremities | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Sensory and motor function in lower extremities |
| Change in Berg Balance scale | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Balance |
| Change in Gait Deviation Index (GDI) | After 4 weeks of training and 6 months after stroke | 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). |
| Change in 2 minutes walk test | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Walking |
| Change in Alberts test | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Neglect |
| Change in EQ5D | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Health outcome |
| Stroke impact scale | 6 months after stroke | Functioning and disability |
| Change in Modified Aschworth scale | Assessed at baseline, after 4 weeks of training and 6 months after stroke | Spasticity |
Countries
Sweden
Outcome results
None listed