Clinical trial NCT02545088: New Technology for Individualised, Intensive Training of Gait After Stroke- Study II
Official title: New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ambulation Difficulty
Hemiparesis
Keywords: Rehabilitation
Robotics
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: University of Tsukuba
name: Sahlgrenska University Hospital
name: Umeå University
First posted: 2015-09-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Change in 6 min walk test
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary outcomes:
measure: Fugl Meyer Scale for lower extremities
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Modified Ashworth Scale
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Spasticity measured with Neuroflexor foot module
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Berg Balance Scale
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: 10 meters walk test
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: 2 minutes walk test
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Functional Ambulation Categories
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Borg Rating of Perceived Exertion Scale (RPE)
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Montreal Cognitive Assessment
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Hospital anxiety and Depression Scale
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Barthel Index
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Stroke Impact Scale
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Physical activity in everyday life using SenseWear
timeFrame: Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Assessment at baseline
measure: Modified Ranking Scale
timeFrame: Assessment at baseline
measure: Body Mass Index
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Weight
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Height
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Blood pressure
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: HbA1c
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Plasma lipid profile
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Perception of the intervention
timeFrame: after 6 weeks of intervention
measure: Smoking
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Alcohol
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Drug use
timeFrame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
measure: Health care consumption
timeFrame: 12 month post intervention
measure: Stroke type and localization
timeFrame: At baseline
measure: Dysexecutive Questionnaire
timeFrame: At baseline
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
References:
citation: Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92.
citation: Wall A, Borg J, Palmcrantz S. Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review. Front Syst Neurosci. 2015 Mar 25;9:48. doi: 10.3389/fnsys.2015.00048. eCollection 2015.
citation: Palmcrantz S, Wall A, Vreede KS, Lindberg P, Danielsson A, Sunnerhagen KS, Hager CK, Borg J. Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke-A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up. Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021.