New Technology for Individualised, Intensive Training of Gait After Stroke- Study II
- Conditions
- StrokeAmbulation DifficultyHemiparesis
- Interventions
- Device: Hybrid Assistive Limb (HAL)Other: 2nd control groupOther: 1st control group
- Registration Number
- NCT02545088
- Lead Sponsor
- Danderyd Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Hybrid Assistive Limb (HAL) Hybrid Assistive Limb (HAL) - 2nd control group 2nd control group - 1st control group 1st control group -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Modified Ranking Scale Assessment at baseline Interview
2 minutes walk test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Walking
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
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
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
Stroke Impact Scale Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Functioning and disability, Interview
Barthel Index Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Independence in mobility and personal care
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
Plasma lipid profile Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Blood test
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) Assessment at baseline Stroke severity
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
Perception of the intervention after 6 weeks of intervention Interview. Study group using Hybrid Assistive Limb (HAL) only.
Smoking Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Interview
Alcohol Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention Interview
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
Trial Locations
- Locations (1)
Department of Rehabilitation Medicine, Danderyd Hospital
🇸🇪Danderyd, Stockholm, Sweden