StrokeNCT03653780

Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke

A study testing Ekso GT in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.

Completed

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

Trial summary

To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Ekso GT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteBelgium
Study dates: 27 Aug 2018to 1 Feb 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Included will be persons who

Had a stroke (1 week to 6 months since injury)
Are 18 years or older
Cannot walk independently or can walk independently on level ground, but require help on stairs, slopes or uneven surfaces (FAC 0 - 4)
Have prior experience with the Ekso GT (i.e. 4 training sessions)

Excluded will be persons who

Can walk independently on level ground, stairs, slopes and uneven surfaces (FAC = 5)
Have musculoskeletal problems (other than stroke) affecting the ability to walk
Have concurrent pulmonary diseases (e.g. asthma)
Have unstable cardiovascular conditions
Have concurrent neurological diseases (e.g. Parkinson's Disease)
Have communicative and/or cognitive problems affecting the ability to understand or follow instructions
Present contra-indications for using the Ekso GT (according to manufacturer's instructions)
Severe concurrent medical diseases (infections, circulatory, heart or lung, pressure sores)
Severe spasticity (Ashworth 4)
Range of motion restrictions that would prevent a patient from achieving normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions
Bilateral hip flexion < 110°
Knee flexion contracture > 12°
Inability to achieve 0° neutral angle dorsiflexion with knee flexion ≤ 12°
Weight ≥ 100 kg
Hip width < 35.8 cm or > 45.6 cm
Upper leg length < 51 cm or > 61.4 cm
Lower leg length < 48 cm or > 63.4 cm
Upper leg length discrepancy > 0.5 inch (1.3 cm)
Lower leg length discrepancy > 0.75 inch (1.9 cm)
Unstable spine, unhealed limbs or pelvic fractures
Unhealthy bone density
Heterotopic ossification
Significant contractures
Elbows and shoulders cannot support crutches, walker or cane
Psychiatric or cognitive situations that may interfere with proper operation of the device

Trial locations and contacts

1 site in 1 country.

Belgium1 site

RevArte Rehabilitation Hospital
Edegem, Antwerp, 2650

Other trials in Belgium

About this study

To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke

Read the detailed description

STUDY DESIGN: An experimental, 1-group trial

PATIENT RECRUITMENT: A minimum of 10 subjects will be included in the study. Patients will be recruited at the Revarte Rehabilitation Hospital (Edegem, Belgium).

ELIGIBILITY CRITERIA: see section "Eligibility"

PROCEDURES: The trial will be conducted at the Revarte Rehabilitation Hospital (Edegem, Belgium).

Before the start of the study, informed consent and baseline patient characteristics will be collected.

On a separate day before the start of the 5th training session, patients will be seated for 5 minutes during which resting values (respiratory gases and heart rate) will be assessed.

Next, participants will be measured during their 5th training session with the Ekso GT with maximum bilateral assistance. Following settings will be used: sitting program ("Min lean"); standing program ("Auto lean"); step initiation program ("ProStep+"), training mode ("Both"), assistance mode ("Bilat"), swing assistance ("Max"), stance support ("Full").

At the start of the 5th training, a mouth mask, heart rate monitor and gait analysis system will be applied. After a seated resting period of 5 minutes, patients will walk for a total of 20 minutes during which respiratory gases and heart rate will be monitored continuously. The Borg rating of perceived exertion will be registered every 5 minutes. The intervention will be terminated early when relative or absolute indications are presented as reported by the American Heart Association or when patients are unable to continue walking.

During training, patients will walk at a self-selected walking speed.

RESTRICTIONS \& PROHIBITIONS: Participants will be instructed to not consume food, alcohol, caffeine or nicotine at least 3h prior to the intervention. Usual medication intake will be allowed with small amounts of water.

MATERIALS: During the overground gait training sessions, the Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be used. A flexible facemask (adult facemask, small/medium, Cortex, Germany), lightweight chest carrying gas analysis system (Metamax 3B, Cortex, Germany) and Bluetooth heart rate belt (Polar H7, Polar Electro, Finland) will be used to measure metabolic and cardiorespiratory parameters. At the start of each measurement, gas (room air and reference gas (17.4% O2 and 5.1% CO2)) and volume (3L syringe) calibrations of the breath-by-breath gas analysis system will be performed in accordance with the manufacturer's instructions.

OUTCOMES: See section "Outcome measures"

Conditions: Stroke
Being tested: Ekso GT
Keywords: Wearable Exoskeleton, Stroke, Oxygen Consumption, Cardiorespiratory Responses
Medical subject headings: Stroke

What participants receive

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

Ekso GTDevice
Walking in the Ekso GT with maximum bilateral assistance for 20 minutes

Study groups in NCT03653780
Study group	Role	What they receive
Ekso GT gait training	Experimental	20-minute Ekso GT gait training Receives: Device: Ekso GT

What is being measured

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

Net oxygen cost (OC, ml/kg/m) at minute 5 of walking
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Measured: Minute 5 of 20-minute walking period
Net oxygen cost (OC, ml/kg/m) at minute 10 of walking
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Measured: Minute 10 of 20-minute walking period
Net oxygen cost (OC, ml/kg/m) at minute 15 of walking
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Measured: Minute 15 of 20-minute walking period
Net oxygen cost (OC, ml/kg/m) at minute 20 of walking
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Measured: Minute 20 of 20-minute walking period
Net heart rate (HR, beats/min) at minute 5 of walking
Heart rate during walking (beats/min) minus resting heart rate
Measured: Minute 5 of 20-minute walking period
Net heart rate (HR, beats/min) at minute 10 of walking
Heart rate during walking (beats/min) minus resting heart rate
Measured: Minute 10 of 20-minute walking period
Net heart rate (HR, beats/min) at minute 15 of walking
Heart rate during walking (beats/min) minus resting heart rate
Measured: Minute 15 of 20-minute walking period
Net heart rate (HR, beats/min) at minute 20 of walking
Heart rate during walking (beats/min) minus resting heart rate
Measured: Minute 20 of 20-minute walking period
Net minute ventilation (VE, L/min) at minute 5 of walking
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Measured: Minute 5 of 20-minute walking period
Net minute ventilation (VE, L/min) at minute 10 of walking
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Measured: Minute 10 of 20-minute walking period
Net minute ventilation (VE, L/min) at minute 15 of walking
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Measured: Minute 15 of 20-minute walking period
Net minute ventilation (VE, L/min) at minute 20 of walking
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Measured: Minute 20 of 20-minute walking period
Net respiratory exchange ratio (RER, no unit) at minute 5 of walking
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Measured: Minute 5 of 20-minute walking period
Net respiratory exchange ratio (RER, no unit) at minute 10 of walking
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Measured: Minute 10 of 20-minute walking period
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Measured: Minute 15 of 20-minute walking period
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Measured: Minute 20 of 20-minute walking period

Secondary outcomes (4)

Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking
Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Measured: Minute 5 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking
Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Measured: Minute 10 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking
Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Measured: Minute 15 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking
Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Measured: Minute 20 of 20-minute walking period

Timeline

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

27 Aug 20181 Feb 2019

First posted31 Aug 2018
Study start27 Aug 2018
Primary completion1 Feb 2019
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03653780
Sponsor's protocol ID: EKSO STUDY II
Status last verified: Feb 2019
First submitted: 29 Aug 2018
Last updated: 6 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
ClinicalTrials.gov ID: NCT03653780
Acronym / sponsor ID: EKSO STUDY II
Conditions: Stroke
Keywords: Wearable Exoskeleton, Stroke, Oxygen Consumption, Cardiorespiratory Responses
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Vrije Universiteit BrusselUniversity, hospital or other
Study start: 27 Aug 2018 (actual)
Primary completion: 1 Feb 2019 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 31 Aug 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.

To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke

Detailed description

STUDY DESIGN: An experimental, 1-group trial

PATIENT RECRUITMENT: A minimum of 10 subjects will be included in the study. Patients will be recruited at the Revarte Rehabilitation Hospital (Edegem, Belgium).

ELIGIBILITY CRITERIA: see section "Eligibility"

PROCEDURES: The trial will be conducted at the Revarte Rehabilitation Hospital (Edegem, Belgium).

Before the start of the study, informed consent and baseline patient characteristics will be collected.

On a separate day before the start of the 5th training session, patients will be seated for 5 minutes during which resting values (respiratory gases and heart rate) will be assessed.

During training, patients will walk at a self-selected walking speed.

OUTCOMES: See section "Outcome measures"

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ekso GT gait training	Experimental	Device: Ekso GT20-minute Ekso GT gait training

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Ekso GTWalking in the Ekso GT with maximum bilateral assistance for 20 minutes	Device	Ekso GT gait training

Primary outcome

Net oxygen cost (OC, ml/kg/m) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net heart rate (HR, beats/min) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net heart rate (HR, beats/min) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net heart rate (HR, beats/min) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net heart rate (HR, beats/min) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net minute ventilation (VE, L/min) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net minute ventilation (VE, L/min) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net minute ventilation (VE, L/min) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net minute ventilation (VE, L/min) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net respiratory exchange ratio (RER, no unit) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net respiratory exchange ratio (RER, no unit) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
Time frame: Minute 20 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest

4 secondary outcomes

Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking
Time frame: Minute 15 of 20-minute walking period
Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period

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 6 Feb 2019.

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

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.

Eric Kerckhofs, PhD study chair

Vrije Universiteit Brussel

Eva Swinnen, PhD study director

Vrije Universiteit Brussel

Nina Lefeber, PhD student principal investigator

Vrije Universiteit Brussel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ekso GT in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.

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

Who may be eligible to take part?

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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Net oxygen cost (OC, ml/kg/m) at minute 5 of walking (time frame: Minute 5 of 20-minute walking period). The study lists 16 primary outcomes in all. 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 NCT03653780.

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 6 Feb 2019.