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StrokeTARGETNCT03728036

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

An observational study of Stroke and Paresis, run by Universiteit Antwerpen at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke, Paresis, Gait, Hemiplegic
What is being tested?
conventional rehabilitation
How many people
66 participants
Where
3 sitesBelgium
Study dates
1 Nov 2018to 7 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the neurology department of the Antwerp University Hospital after acute stroke will be contacted and asked to participate. Information about the study's aim will be provided with a clear understanding of what is expected from the participant. If the patient express willingness to enter the study, the examination on in- and exclusion criteria will be performed. If the patient is considered eligible, an informed consent will be signed.

Who may be able to join

  • 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

Who cannot join

  • No other neurological condition affecting motor functions of the lower limbs
  • Pre-existing musculoskeletal impairment severely affecting the gait pattern

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Antwerp University Hospital

    Antwerp

  • RevArte Rehabilitation Hospital

    Antwerp

  • GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

    Wilrijk, 2610

Other trials in Belgium

About this study

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

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

Read the 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?

Being tested
conventional rehabilitation
Keywords
walking, recovery, compensation
Medical subject headings
Stroke, Paresis, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional rehabilitationBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Ambulation Categories

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

    Measured: 12 weeks post-stroke]

Secondary outcomes (8)

  1. 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)

    Measured: Baseline (0-1 week post-stroke)

  2. 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).

    Measured: 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

  3. 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).

    Measured: 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

  4. 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).

    Measured: 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

  5. 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).

    Measured: 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

  6. 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.

    Measured: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

  7. 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.

    Measured: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

  8. Spatio-temporal analyses of gait

    Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance.

    Measured: 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start1 Nov 2018
  3. Primary completion7 Feb 2022
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728036
Sponsor's protocol ID
JS-1
Other IDs
1S64819N
Acronym
TARGET
Status last verified
Sep 2022
First submitted
24 Oct 2018
Last updated
23 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schroder J, Saeys W, Embrechts E, Hallemans A, Yperzeele L, Truijen S, Kwakkel G. Recovery of Quiet Standing Balance and Lower Limb Motor Impairment Early Poststroke: How Are They Related? Neurorehabil Neural Repair. 2023 Aug;37(8):530-544. doi: 10.1177/15459683231186983. Epub 2023 Aug 19.

    PubMed 37596887

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Paresis, run by Universiteit Antwerpen at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Categories (time frame: 12 weeks post-stroke]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.

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