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Completed

NCT Number: NCT03728036

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital, Antwerp, Belgium

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional rehabilitation

Behavioral

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

Primary outcomes

  1. Functional Ambulation Categories

    Time frame: 12 weeks post-stroke]

    This scale indicates the ability to walk independently and serves as the primary outcome measure.

Secondary outcomes

  1. Trunk Control Test - item sitting balance

    Time frame: Baseline (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)

  2. Motricity Index - subscale lower limb

    Time frame: 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

    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).

  3. Fugl Meyer Motor Assessment - subscale lower limb

    Time frame: 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

    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).

  4. Berg Balance Scale - item standing unsupported

    Time frame: 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

    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).

  5. Functional Ambulation Categories

    Time frame: 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

    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).

  6. Kinetic analyses of standing balance & gait

    Time frame: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

    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.

  7. EMG analyses of standing balance & gait

    Time frame: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

    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.

  8. Spatio-temporal analyses of gait

    Time frame: 3 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.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

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

Acronym: TARGET

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2018
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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