Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 64
Summary
- Conditions
- Gait, Hemiplegic
- Paresis
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: A single blinded assessor will be allocated to a certain participant. This means that he/she will perform the assessment (FAC, 10-m Walk Test, FM, MI) across the different repeated measurements within the same participant, to reduce bias from inter-assessor variability in performing and evaluating a clinical test.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 perio...
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?
Tracking Information
- NCT #
- NCT03727919
- Collaborators
- University Hospital, Antwerp
- Investigators
- Principal Investigator: Jonas Schröder, PhD Student Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium Study Director: Wim Saeys, Prof. Dr. Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium Study Chair: Steven Truijen, Prof. Dr. Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium Study Chair: Gert Kwakkel, Prof. Dr. Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands