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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03728036
Acronym
TARGET
Enrollment
66
Registered
2018-11-01
Start date
2018-11-01
Completion date
2022-02-07
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Hemiplegic, Paresis, Stroke

Keywords

walking, recovery, compensation

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?

Interventions

BEHAVIORALconventional rehabilitation

The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.

Sponsors

University Hospital, Antwerp
CollaboratorOTHER
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Ambulation Categories12 weeks post-stroke]This scale indicates the ability to walk independently and serves as the primary outcome measure.

Secondary

MeasureTime frameDescription
Motricity Index - subscale lower limbBaseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeStrength 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).
Fugl Meyer Motor Assessment - subscale lower limbBaseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeThis 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).
Berg Balance Scale - item standing unsupportedBaseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeThis 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).
Trunk Control Test - item sitting balanceBaseline (0-1 week post-stroke)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)
Kinetic analyses of standing balance & gait3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeDual-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.
EMG analyses of standing balance & gait3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeEMG 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.
Spatio-temporal analyses of gait3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke.Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance.
Functional Ambulation CategoriesBaseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-strokeThis 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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026