What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study
NCT ID: NCT03728036
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2018-11-01
2022-02-07
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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conventional rehabilitation
The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-existing musculoskeletal impairment severely affecting the gait pattern
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Jonas Schröder
Principle investigator, PhD researcher
Principal Investigators
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Jonas Schröder, PhD Student
Role: PRINCIPAL_INVESTIGATOR
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Wim Saeys, Prof. Dr.
Role: STUDY_DIRECTOR
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Steven Truijen, Prof. Dr.
Role: STUDY_CHAIR
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Gert Kwakkel, Prof. Dr.
Role: STUDY_CHAIR
Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands
Locations
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Antwerp University Hospital
Antwerp, , Belgium
RevArte Rehabilitation Hospital
Antwerp, , Belgium
GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius
Wilrijk, , Belgium
Countries
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References
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Schroder J, Saeys W, Embrechts E, Hallemans A, Yperzeele L, Truijen S, Kwakkel G. Recovery of Quiet Standing Balance and Lower Limb Motor Impairment Early Poststroke: How Are They Related? Neurorehabil Neural Repair. 2023 Aug;37(8):530-544. doi: 10.1177/15459683231186983. Epub 2023 Aug 19.
Other Identifiers
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1S64819N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
JS-1
Identifier Type: -
Identifier Source: org_study_id
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