Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study
- Conditions
- ParesisGait, HemiplegicStroke
- Interventions
- Behavioral: Exoskeleton-assisted gait training
- Registration Number
- NCT03727919
- Lead Sponsor
- Universiteit Antwerpen
- Brief Summary
Phase II: Investigating the effects of additional robot-assisted gait training either initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.
- Detailed Description
GENERAL:
Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. For example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. The typically observed non-linear recovery pattern in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse.
In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of robot-assisted training (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. To initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice.
OBJECTIVES:
(II.a) Are stroke survivors who train with the assistance of a robot at an early stage more likely to achieve independent walking?
(II.b) Does additional robot-assisted training modulate the recovery of standing and walking ability by enhancing behavioral restitution?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
- Age: 18 - 90 years
- Baseline assessments within the first 14 days after stroke onset
- Unable to walk independently at baseline (FAC <3)
- Moderate to severe weakness of the lower limb at baseline (MI </=75)
- Pre-morbid independence in activities of daily living (mRS </=2) and gait (FAC >3)
- Able to communicate and comprehend
- Sufficient motivation to participate
- Provided a written informed consent
- No other neurological condition affecting motor functions of the lower limbs
- Pre-existing musculoskeletal impairment severely affecting the gait pattern
- Body weight > 100 kg
- Severe spasticity or contractures that prevent safe use of the exoskeleton
- Medically unstable to participate in additional therapy sessions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Experimental Group Exoskeleton-assisted gait training N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided within the first 6 weeks post-stroke Delayed Experimental Group Exoskeleton-assisted gait training N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided between week 8 and week 12 post-stroke
- Primary Outcome Measures
Name Time Method Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE) Longitudinal change is determined between the following time points: Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke This scale measures the level of of volitional, selective control of muscles of the paretic lower limb.
Scoring: This scale is scored from 0 (no reflex activity) to 34 (volitional movement out of synergies).
- Secondary Outcome Measures
Name Time Method Kinetic analyses of standing balance & gait 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke Dual-force plate measurements are able to indicate the adopted control strategies for standing balance and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies.
Spatio-temporal analyses of gait 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke. Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance.
Motricity Index - subscale lower extremity (MI-LE) Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke Strength of major muscle groups of the paretic lower limb is assessed. At baseline this is part of the prognostic model used to stratify patients.
Scoring: This scale is scored from 0 (no muscle activity) to 99 (normal strength over full range of motion in hip flexors, knee extensors and ankle dorsiflexors).Functional Ambulation Categories (FAC) Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke This scale indicates the ability to walk independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke.
Scoring: This scale includes 6 levels (0-5), ranging from "nonfunctional ambulation" (0) to "ambulate independently, on level and non-level surfaces including stairs and inclines" (5).Trunk Control Test - item sitting balance Baseline (0-1 week post-stroke) Sitting balance is part of the prognostic model used to stratify patients at baseline.
Scoring: 0 - 1 (able to sit independently without support of the legs or trunk 30 seconds)Berg Balance Scale - item standing unsupported Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke This item of the BBS indicates the ability to stand independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke.
Scoring: This scale includes 5 levels (0-4), ranging from "unable to stand 30 seconds unassisted" (0) to "able to stand safely 2 minutes" (5).EMG analyses of standing balance & gait 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke EMG analyses will be performed to gain insights in the muscle recruitment of patients during standing and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies.
Trial Locations
- Locations (3)
RevArte Rehabilitation Hospital
🇧🇪Antwerp, Belgium
Antwerp University Hospital
🇧🇪Antwerp, Belgium
GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius
🇧🇪Wilrijk, Antwerp, Belgium