New Technology for Individualised, Intensive Training of Gait After Stroke- Study II

Danderyd Hospital48 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Hybrid Assistive Limb (HAL)DEVICE

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.

1st control groupOTHER

Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.

2nd control groupOTHER

The 2nd control group will not receive an intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in 6 min walk test

walking ability and endurance

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Secondary Outcomes

Fugl Meyer Scale for lower extremities

Sensory and motor function in lower extremities

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Modified Ashworth Scale

Spasticity

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Spasticity measured with Neuroflexor foot module

Spasticity

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Berg Balance Scale

Balance

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

10 meters walk test

Walking

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

2 minutes walk test

Walking

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Functional Ambulation Categories

Walking

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Borg Rating of Perceived Exertion Scale (RPE)

Interview

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Montreal Cognitive Assessment

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Hospital anxiety and Depression Scale

Interview

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Barthel Index

Independence in mobility and personal care

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Stroke Impact Scale

Functioning and disability, Interview

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Physical activity in everyday life using SenseWear

Registers physical activity in everyday life

Time frame: Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention

Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)

Stroke severity

Time frame: Assessment at baseline

Modified Ranking Scale

Interview

Time frame: Assessment at baseline

Body Mass Index

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Weight

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Height

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Blood pressure

Registered in everyday life

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

HbA1c

Blood test

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Plasma lipid profile

Blood test

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Perception of the intervention

Interview. Study group using Hybrid Assistive Limb (HAL) only.

Time frame: after 6 weeks of intervention

Smoking

Interview

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Alcohol

Interview

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Drug use

From medical records

Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Health care consumption

From County Council

Time frame: 12 month post intervention

Stroke type and localization

From medical records

Time frame: At baseline

Dysexecutive Questionnaire

Filled in by significant other

Time frame: At baseline

New Technology for Individualised, Intensive Training of Gait After Stroke- Study II

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes