StrokeNCT03367091

Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke

A study testing Ekso GT gait training with high swing assistance, Ekso GT gait training with neutral swing assistance and Ekso GT gait training with high swing resistance in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To investigate acute metabolic and cardiorespiratory responses during 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 gait training with high swing assistance, Ekso GT gait training with neutral swing assistance and Ekso GT gait training with high swing resistance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteBelgium
Study dates: 9 Jul 2018to 31 Dec 2018
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
Cannot walk independently or can walk independently on level ground, but still require help on stairs, slopes or uneven surfaces (FAC 0 - 4)

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 are unable to 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

REVAlution center
Herentals, Antwerp, 2200

Other trials in Belgium

About this study

Official title: Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance

To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke

Read the detailed description

RESEARCH AIMS:

To investigate the effect of the level of swing assistance on the acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
To investigate if there is an interaction-effect between the level of swing assistance and the duration of walking
To compare the exercise intensity to aerobic training recommendations

STUDY DESIGN: An experimental, 1-group trial with randomized crossover design.

PATIENT RECRUITMENT: Participants will be recruited at the AZ Herentals (Herentals, Belgium).

LOCATION: The trial will be conducted at the REVAlution Center (Herentals, Belgium).

ELIGIBILITY CRITERIA: See section "Eligibility"

PROCEDURES: Before the start of the study, informed consent and baseline patient characteristics will be collected. Next, participants will be measured during three training sessions with the Ekso GT SmartAssist:

20-minute training with high swing assistance
20-minute training with neutral swing assistance
20-minute training with high swing resistance

Trainings will be performed on a separate day in a randomized order (within one week and controlled for time of day).

Following settings will be used in all three conditions: sitting program ("Min lean"); standing program ("Auto lean"); step initiation program ("ProStep+"), training mode ("Off"), SmartAssist option ("2Free"); and stance support ("Low"). The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.

During training, participants will walk back and forth at a self-selected walking speed in a 30m hall way using a cane at the non-affected side.

Prior to the experimental conditions, participants will have had three training sessions in the Ekso GT.

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: The Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be used during the overground training sessions.

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"

DATA-ANALYSES: Descriptive statistics will be calculated for baseline patient characteristics. To investigate the effect of level of swing assistance and duration, a repeated measures ANOVA (within factor duration and within factor assistance level) will be conducted (interaction-effect time x duration, main effect assistance level and main effect duration). In case of significant differences, posthoc analyses will be interpreted. The walking speed will be considered as a covariate in the ANOVA analysis (in case significant different between conditions). Significance level will be set at 5%.

Conditions: Stroke
Being tested: Ekso GT gait training with high swing assistance, Ekso GT gait training with neutral swing assistance, Ekso GT gait training with high swing resistance
Keywords: Wearable Exoskeleton, Stroke, Energy Consumption, Cardiorespiratory Load
Medical subject headings: Stroke

What participants receive

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

Ekso GT gait training with high swing assistanceOther
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high assistance"
Ekso GT gait training with neutral swing assistanceOther
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "neutral"
Ekso GT gait training with high swing resistanceOther
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high resistance"

Study groups in NCT03367091
Study group	Role	What they receive
Ekso GT gait training	Experimental	Participants will be measured during three Ekso GT gait trainings: * 20-minute Ekso GT gait training with high swing assistance * 20-minute Ekso GT gait training with neutral swing assistance * 20-minute Ekso GT gait training with high swing resistance. Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day). Receives: Other: Ekso GT gait training with high swing assistance; Other: Ekso GT gait training with neutral swing assistance; Other: Ekso GT gait training with high swing resistance

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

Secondary outcomes (16)

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 15 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
Percentage maximal heart rate (%HRmax) at minute 5 of walking
Heart rate divided by predicted maximum heart rate.
Measured: Minute 5 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 10 of walking
Heart rate divided by predicted maximum heart rate.
Measured: Minute 10 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 15 of walking
Heart rate divided by predicted maximum heart rate.
Measured: Minute 15 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 20 of walking
Heart rate divided by predicted maximum heart rate.
Measured: Minute 20 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 5 of walking
Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Measured: Minute 5 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 10 of walking
Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Measured: Minute 10 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 15 of walking
Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Measured: Minute 15 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 20 of walking
Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Measured: Minute 20 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 5 of walking
Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Measured: Minute 5 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 10 of walking
Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Measured: Minute 10 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 15 of walking
Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Measured: Minute 15 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 20 of walking
Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in 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.

9 Jul 201831 Dec 2018

First posted8 Dec 2017
Study start9 Jul 2018
Primary completion31 Dec 2018
Study completion31 Dec 2018

Why it stopped: Organisational/Recruitment Issues

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.
More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
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: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03367091
Sponsor's protocol ID: EKSO STUDY I
Status last verified: Feb 2019
First submitted: 30 Nov 2017
Last updated: 7 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance
ClinicalTrials.gov ID: NCT03367091
Acronym / sponsor ID: EKSO STUDY I
Conditions: Stroke
Keywords: Wearable Exoskeleton, Stroke, Energy Consumption, Cardiorespiratory Load
Study type: Interventional
Recruitment status: TerminatedReason stopped: Organisational/Recruitment Issues
Enrolment: 1 participants (actual)
Lead sponsor: Vrije Universiteit BrusselUniversity, hospital or other
Study start: 9 Jul 2018 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 8 Dec 2017 (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 acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke

Detailed description

RESEARCH AIMS:

To investigate the effect of the level of swing assistance on the acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
To investigate if there is an interaction-effect between the level of swing assistance and the duration of walking
To compare the exercise intensity to aerobic training recommendations

STUDY DESIGN: An experimental, 1-group trial with randomized crossover design.

PATIENT RECRUITMENT: Participants will be recruited at the AZ Herentals (Herentals, Belgium).

LOCATION: The trial will be conducted at the REVAlution Center (Herentals, Belgium).

ELIGIBILITY CRITERIA: See section "Eligibility"

20-minute training with high swing assistance
20-minute training with neutral swing assistance
20-minute training with high swing resistance

Trainings will be performed on a separate day in a randomized order (within one week and controlled for time of day).

During training, participants will walk back and forth at a self-selected walking speed in a 30m hall way using a cane at the non-affected side.

Prior to the experimental conditions, participants will have had three training sessions in the Ekso GT.

MATERIALS: The Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be used during the overground training sessions.

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	Other: Ekso GT gait training with high swing assistance, Other: Ekso GT gait training with neutral swing assistance, Other: Ekso GT gait training with high swing resistanceParticipants will be measured during three Ekso GT gait trainings: * 20-minute Ekso GT gait training with high swing assistance * 20-minute Ekso GT gait training with neutral swing assistance * 20-minute Ekso GT gait training with high swing resistance. Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day).

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 GT gait training with high swing assistanceParticipant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high assistance"	Other	Ekso GT gait training
Ekso GT gait training with neutral swing assistanceParticipant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "neutral"	Other	Ekso GT gait training
Ekso GT gait training with high swing resistanceParticipant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high resistance"	Other	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

16 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 15 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
Percentage maximal heart rate (%HRmax) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
Percentage maximal heart rate (%HRmax) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
Percentage heart rate reserve (%HRR) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 5 of walking
Time frame: Minute 5 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 10 of walking
Time frame: Minute 10 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 15 of walking
Time frame: Minute 15 of 20-minute walking period
Metabolic Equivalent of Task (MET) at minute 20 of walking
Time frame: Minute 20 of 20-minute walking period

Results and safety

The study was stopped early (reason given: Organisational/Recruitment Issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
Individual participant dataSharing planned: Undecided

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.

Eric Kerckhofs, Prof, PhD study chair

Vrije Universiteit Brussel

Eva Swinnen, Prof, 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?

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: stopped early, as of the sponsor's last update on 7 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 was stopped early (reason given: Organisational/Recruitment Issues). Results are not available in the source record.

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 12 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 NCT03367091.

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 7 Feb 2019.