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Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study (TARGET)

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ClinicalTrials.gov Identifier: NCT03727919
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Jonas Schröder, Universiteit Antwerpen

Brief Summary:
Phase II: Investigating the effects of additional robot-assisted gait training either initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.

Condition or disease Intervention/treatment Phase
Stroke Paresis Gait, Hemiplegic Behavioral: Exoskeleton-assisted gait training Not Applicable

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:

(II.a) Are stroke survivors who train with the assistance of a robot at an early stage more likely to achieve independent walking?

(II.b) Does additional robot-assisted training modulate the recovery of standing and walking ability by enhancing behavioral restitution?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A single blinded assessor will be allocated to a certain participant. This means that he/she will perform the assessment (FAC, 10-m Walk Test, FM, MI) across the different repeated measurements within the same participant, to reduce bias from inter-assessor variability in performing and evaluating a clinical test.
Primary Purpose: Treatment
Official Title: A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Early Experimental Group
N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided within the first 6 weeks post-stroke
Behavioral: Exoskeleton-assisted gait training
In the experimental groups, participants are provided with 1-hour sessions of gait training with robot assistance, 4 times per week for 4 weeks. Assistance is provided by the Ekso GT (Ekso Bionics, Richmond, CA, USA), an exoskeleton consisting of fitted metal braces that supports the legs, feet, and trunk of the patient. Powered motors drive knee and hip joints in the sagittal plane to assist during standing up and walking over level surfaces. Steps are initiated if an active weight-shift towards the stance leg is performed by the patient. The provided assistance in stance and swing is adaptable to the patient's ability and can be adjusted for each leg separately.

Experimental: Delayed Experimental Group
N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided between week 8 and week 12 post-stroke
Behavioral: Exoskeleton-assisted gait training
In the experimental groups, participants are provided with 1-hour sessions of gait training with robot assistance, 4 times per week for 4 weeks. Assistance is provided by the Ekso GT (Ekso Bionics, Richmond, CA, USA), an exoskeleton consisting of fitted metal braces that supports the legs, feet, and trunk of the patient. Powered motors drive knee and hip joints in the sagittal plane to assist during standing up and walking over level surfaces. Steps are initiated if an active weight-shift towards the stance leg is performed by the patient. The provided assistance in stance and swing is adaptable to the patient's ability and can be adjusted for each leg separately.

No Intervention: Control Group
N = 20 Intervention = standard care including conventional physiotherapy



Primary Outcome Measures :
  1. Functional Ambulation Categories [ Time Frame: 12 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).



Secondary Outcome Measures :
  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 volitional, 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Unable to walk independently at baseline (FAC <3)
  • Moderate to severe weakness of the lower limb at baseline (MI </=75)
  • 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
  • Body weight > 100 kg
  • Severe spasticity or contractures that prevent safe use of the exoskeleton
  • Medically unstable to participate in additional therapy sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727919


Contacts
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Contact: Jonas Schröder, PhD Student +32473730164 jonas.schroder@uantwerpen.be

Locations
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Belgium
GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius Recruiting
Wilrijk, Antwerp, Belgium, 2610
Contact: Frederik Debruyne, Dr.    +32 3 443 30 11      
Antwerp University Hospital Recruiting
Antwerp, Belgium
Contact: Laetitia Yperzeele, Dr.    +32 3 821 34 23    neurologie@uza.be   
RevArte Rehabilitation Hospital Recruiting
Antwerp, Belgium
Contact: Christophe Lafosse, Prof. Dr.    +32 3 210 60 90    revarte@revarte.be   
Sponsors and Collaborators
Universiteit Antwerpen
University Hospital, Antwerp
Investigators
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Principal Investigator: Jonas Schröder, PhD Student Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Director: Wim Saeys, Prof. Dr. Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Chair: Steven Truijen, Prof. Dr. Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Chair: Gert Kwakkel, Prof. Dr. Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands

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Responsible Party: Jonas Schröder, Principle investigator, PhD researcher, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03727919    
Other Study ID Numbers: JS-2
1S64819N ( Other Grant/Funding Number: Fonds Wetenschappelijk Onderzoek (Brussel, Flanders) )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonas Schröder, Universiteit Antwerpen:
stroke
rehabilitation
robotics
Additional relevant MeSH terms:
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Stroke
Paresis
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms