What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study

Universiteit Antwerpen

Status: Completed

Conditions: Stroke; Gait, Hemiplegic; Paresis

Treatments: Behavioral: conventional rehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT03728036

JS-1

1S64819N (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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?

Enrollment: 66 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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