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

Study Overview
=================
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?

Official Title
-----------------
A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project

Conditions
-----------------
Stroke, Paresis, Gait, Hemiplegic

Intervention / Treatment
-----------------
* Behavioral: conventional rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: conventional rehabilitation|The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Categories | This scale indicates the ability to walk independently and serves as the primary outcome measure. | 12 weeks post-stroke] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Control Test - item sitting balance | Sitting balance is part of the prognostic model used to stratify patients at baseline. Scoring: 0 - 1 (able to sit independently without support of the legs or trunk 30 seconds) | Baseline (0-1 week post-stroke) | 
| Motricity Index - subscale lower limb | Strength of major muscle groups of the paretic lower limb is assessed. At baseline this is part of the prognostic model used to stratify patients. Scoring: This scale is scored from 0 (no muscle activity) to 99 (normal strength over full range of motion in hip flexors, knee extensors and ankle dorsiflexors). | 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 | 
| Fugl Meyer Motor Assessment - subscale lower limb | This scale measures the level of of selective control of muscles of the paretic lower limb. Scoring: This scale is scored from 0 (no reflex activity) to 34 (volitional movement out of synergism). | 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 | 
| Berg Balance Scale - item standing unsupported | This item of the BBS indicates the ability to stand independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke. Scoring: This scale includes 5 levels (0-4), ranging from unable to stand 30 seconds unassisted (0) to able to stand safely 2 minutes (5). | 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 | 
| Functional Ambulation Categories | This scale indicates the ability to walk independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke. Scoring: This scale includes 6 levels (0-5), ranging from nonfunctional ambulation (0) to ambulate independently, on level and non-level surfaces including stairs and inclines (5). | 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 | 
| Kinetic analyses of standing balance & gait | Dual-force plate measurements are able to indicate the adopted control strategies for standing balance and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke | 
| EMG analyses of standing balance & gait | EMG analyses will be performed to gain insights in the muscle recruitment of patients during standing and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke | 
| Spatio-temporal analyses of gait | Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
walking, recovery, compensation