Clinical trial NCT03728036: What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study
Official title: A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Paresis
Gait, Hemiplegic
Keywords: walking
recovery
compensation
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2018-11-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the neurology department of the Antwerp University Hospital after acute stroke will be contacted and asked to participate. Information about the study's aim will be provided with a clear understanding of what is expected from the participant. If the patient express willingness to enter the study, the examination on in- and exclusion criteria will be performed. If the patient is considered eligible, an informed consent will be signed.

Brief summary: Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk.

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:

(I.a) Is there a distinct time window of behavioral restitution (i.e., returning towards pre-stroke movement patterns) underlying early walking recovery?

(I.b) Are improvements in standing and walking throughout the first 6 months post-stroke explained by behavioral restitution or learning to use compensation strategies?

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
* Weakness of the lower limb (NIHSS item \>0 at 72 hours post-stroke)
* 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

Primary outcomes:
measure: Functional Ambulation Categories
timeFrame: 12 weeks post-stroke]
Secondary outcomes:
measure: Trunk Control Test - item sitting balance
timeFrame: Baseline (0-1 week post-stroke)
measure: Motricity Index - subscale lower limb
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: Fugl Meyer Motor Assessment - subscale lower limb
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
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: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Antwerp
country: Belgium
facility: RevArte Rehabilitation Hospital
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius
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_DIRECTOR
affiliation: Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
name: Steven Truijen, Prof. Dr.
role: STUDY_CHAIR
affiliation: Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands
name: Gert Kwakkel, Prof. Dr.
role: STUDY_CHAIR
References: