New Technology for Individualised, Intensive Training of Gait After Stroke- Study II "HAL-RCT-II"
Recruiting
Phase N/A Results N/ATrial Description
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
Conditions
Interventions
- Hybrid Assistive Limb (HAL) Device
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Study group Hybrid Assistive Limb (HAL) Description: . - 1st control group Other
Intervention Desc: Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. ARM 1: Kind: Experimental Label: 1st control group Description: . - 2nd control group Other
Intervention Desc: The 2nd control group will not receive an intervention. ARM 1: Kind: Experimental Label: 2nd control group Description: .
Trial Design
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Intervention: Parallel Assignment
Outcomes
Type | Measure | Time Frame | Safety Issue |
---|---|---|---|
Primary | Change in Functional Ambulation Categories (FAC) | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Fugl Meyer Scale for lower extremities | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Modified Ashworth Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Spasticity measured with Neuroflexor foot module | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Berg Balance Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | 10 meters walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | 2 minutes walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | 6 minutes walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Borg Rating of Perceived Exertion Scale (RPE) | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Montreal Cognitive Assessment | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Hospital anxiety and Depression Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Barthel Index | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Stroke Impact Scale | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | 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 | No |
Secondary | Gait Deviation Index (GDI) (Laboratory gait analysis) | Assessment at baseline, after 6 weeks of intervention and 6 month post intervention | No |
Secondary | Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) | Assessment at baseline | No |
Secondary | Modified Ranking Scale | Assessment at baseline | No |
Secondary | Body Mass Index | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Weight | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Height | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Blood pressure | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | HbA1c | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Plasma lipid profile | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Perception of the intervention | after 6 weeks of intervention | No |
Secondary | Energy expenditure | during the 6 weeks of intervention | No |
Secondary | Smoking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Alcohol | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Drug use | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | No |
Secondary | Health care consumption | 12 month post intervention | No |
Secondary | Stroke type and localization | At baseline | No |
Secondary | Dysexecutive Questionnaire | At baseline | No |
Primary | Change in 6 min walk test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | |
Secondary | Functional Ambulation Categories | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention |
Sponsors
View Trial Locations
Recruitment
- Enrollment: 54
- Gender: All
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: No
- 1 location, 1 country