StrokeTARGETNCT03727919
Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study
A study testing Exoskeleton-assisted gait training in people with Stroke and Paresis, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Paresis, Gait, Hemiplegic
- What is being tested?
- Exoskeleton-assisted gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Nov 2018to 7 Feb 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- 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)
Show all 9Show fewer
- 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
- Body weight > 100 kg
- Severe spasticity or contractures that prevent safe use of the exoskeleton
- Medically unstable to participate in additional therapy sessions
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, Antwerp, 2610
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 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.
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:
(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?
- Conditions
- Stroke, Paresis, Gait, Hemiplegic
- Being tested
- Exoskeleton-assisted gait training
- Keywords
- stroke, rehabilitation, robotics
- 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.
Exoskeleton-assisted gait trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Experimental Group | Experimental | 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 Receives: Behavioral: Exoskeleton-assisted gait training |
| Delayed Experimental Group | Experimental | 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 Receives: Behavioral: Exoskeleton-assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)
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 synergies).
Measured: Longitudinal change is determined between the following time points: 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
Secondary outcomes (7)
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)
Motricity Index - subscale lower extremity (MI-LE)
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
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
Functional Ambulation Categories (FAC)
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
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
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
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.
- First posted1 Nov 2018
- Study start1 Nov 2018
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the "early group" or "delayed group". Both groups will be provided a dose- and content-controlled intervention in addition to usual care. The early group will receive this intervention at approximately 2 weeks post-stroke and the delayed group at 8 weeks post-stroke. As such, this study is explicitly designed to investigate the effects of time to initiate rehabilitation on recovery outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Jonas Schröder, Universiteit Antwerpen
- Investigators
- Jonas Schröder, PhD Student, Principal investigator, Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, BelgiumWim Saeys, Prof. Dr., Study chair, Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, BelgiumSteven Truijen, Prof. Dr., Study director, Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727919
- Sponsor's protocol ID
- JS-2
- Other IDs
- 1S64819N
- Acronym
- TARGET
- Status last verified
- Apr 2022
- First submitted
- 24 Oct 2018
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schroder J, Yperzeele L, Embrechts E, Loureiro-Chaves R, Hallemans A, Lafosse C, Truijen S, Kwakkel G, Saeys W. Exoskeleton-assisted training to enhance lower limb motor recovery in subacute stroke: does timing matter? A pilot randomized trial. Front Stroke. 2024 May 14;3:1379083. doi: 10.3389/fstro.2024.1379083. eCollection 2024.
PubMed 41542275
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
- ClinicalTrials.gov ID
- NCT03727919
- Acronym / sponsor ID
- TARGET / JS-2
- Conditions
- Stroke, Paresis, Gait, Hemiplegic
- Keywords
- stroke, rehabilitation, robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the "early group" or "delayed group". Both groups will be provided a dose- and content-controlled intervention in addition to usual care. The early group will receive this intervention at approximately 2 weeks post-stroke and the delayed group at 8 weeks post-stroke. As such, this study is explicitly designed to investigate the effects of time to initiate rehabilitation on recovery outcomes.
| Arm | Type | Receives |
|---|---|---|
| Early Experimental Group | Experimental | Behavioral: Exoskeleton-assisted gait trainingN = 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 |
| Delayed Experimental Group | Experimental | Behavioral: Exoskeleton-assisted gait trainingN = 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton-assisted gait trainingIn 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. | Behavioural | Delayed Experimental Group, Early Experimental Group |
Primary outcome
Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)
Time frame: Longitudinal change is determined between the following time points: 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 synergies).
7 secondary outcomes
Trunk Control Test - item sitting balance
Time frame: Baseline (0-1 week post-stroke)
Motricity Index - subscale lower extremity (MI-LE)
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
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
Functional Ambulation Categories (FAC)
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 41542275Schroder J, Yperzeele L, Embrechts E, Loureiro-Chaves R, Hallemans A, Lafosse C, Truijen S, Kwakkel G, Saeys W. Exoskeleton-assisted training to enhance lower limb motor recovery in subacute stroke: does timing matter? A pilot randomized trial. Front Stroke. 2024 May 14;3:1379083. doi: 10.3389/fstro.2024.1379083. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Schröder, PhD Student principal investigator
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Wim Saeys, Prof. Dr. study chair
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Steven Truijen, Prof. Dr. study director
Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton-assisted gait training in people with 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 9 inclusion and 5 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 13 Apr 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?
Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE) (time frame: Longitudinal change is determined between the following time points: 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). 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 NCT03727919, 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 13 Apr 2022.