Clinical trial NCT03727919: Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study
Official title: A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Paresis
Gait, Hemiplegic
Keywords: stroke
rehabilitation
robotics
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2018-11-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the "early group" or "delayed group". Both groups will be provided a dose- and content-controlled intervention in addition to usual care. The early group will receive this intervention at approximately 2 weeks post-stroke and the delayed group at 8 weeks post-stroke. As such, this study is explicitly designed to investigate the effects of time to initiate rehabilitation on recovery outcomes.
Primary purpose: TREATMENT

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?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)
timeFrame: 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
Secondary outcomes:
measure: Trunk Control Test - item sitting balance
timeFrame: Baseline (0-1 week post-stroke)
measure: Motricity Index - subscale lower extremity (MI-LE)
timeFrame: 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
measure: Berg Balance Scale - item standing unsupported
timeFrame: 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
measure: Functional Ambulation Categories (FAC)
timeFrame: 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
measure: Kinetic analyses of standing balance & gait
timeFrame: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke
measure: EMG analyses of standing balance & gait
timeFrame: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke
measure: Spatio-temporal analyses of gait
timeFrame: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke.
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius
state: Antwerp
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Antwerp
country: Belgium
facility: RevArte Rehabilitation Hospital
Study officials:
affiliation: Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
name: Jonas Schröder, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
name: Wim Saeys, Prof. Dr.
role: STUDY_CHAIR
affiliation: Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
name: Steven Truijen, Prof. Dr.
role: STUDY_DIRECTOR
References: