Ambulation Difficulty, Hemiparesis, Stroke
Conditions
Keywords
Rehabilitation, Robotics
Brief summary
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.
Detailed description
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
Interventions
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.
OTHER1st control group
Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
OTHER2nd control group
The 2nd control group will not receive an intervention.
Sponsors
University of Tsukuba
Sahlgrenska University Hospital
Umeå University
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 min walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | walking ability and endurance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Scale for lower extremities | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Sensory and motor function in lower extremities |
| Modified Ashworth Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Spasticity |
| Spasticity measured with Neuroflexor foot module | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Spasticity |
| Alcohol | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Interview |
| Berg Balance Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Balance |
| 10 meters walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Walking |
| 2 minutes walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Walking |
| Functional Ambulation Categories | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Walking |
| Borg Rating of Perceived Exertion Scale (RPE) | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Interview |
| Montreal Cognitive Assessment | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | — |
| Hospital anxiety and Depression Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Interview |
| Barthel Index | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Independence in mobility and personal care |
| Stroke Impact Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Functioning and disability, Interview |
| Smoking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Interview |
| Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) | Assessment at baseline | Stroke severity |
| Modified Ranking Scale | Assessment at baseline | Interview |
| 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 | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Registered in everyday life |
| HbA1c | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Blood test |
| Plasma lipid profile | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | Blood test |
| Perception of the intervention | after 6 weeks of intervention | Interview. Study group using Hybrid Assistive Limb (HAL) only. |
| Drug use | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | From medical records |
| Health care consumption | 12 month post intervention | From County Council |
| Stroke type and localization | At baseline | From medical records |
| Dysexecutive Questionnaire | At baseline | Filled in by significant other |
| Physical activity in everyday life using SenseWear | 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 |
Countries
Sweden
Outcome results
None listed