StrokeNCT02680496
Energy Consumption and Cardiorespiratory Load During Walking With and Without Robot-Assistance
A study testing Lokomat, Treadmill and Overground in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The primary objective of the study is to investigate the energy consumption, cardiorespiratory load and perceived exertion, and how these parameters change, during walking with robot-assistance compared to walking on a treadmill and walking overground in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Lokomat, Treadmill and Overground
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Aug 2017
- 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
Who may be able to join
- Stroke patients with a lower limb motor impairment
- Time since stroke < 1 year
- ≥ 18 years
- < 193 cm
- < 135kg
- Able to walk overground (body-weight support allowed if necessary) for at least 10 minutes at a comfortable walking speed
Who cannot join
- Contra-indications for exercise testing according to the American College of Sports Medicine
- Musculoskeletal problems (other than stroke) affecting the ability to walk
- Concurrent pulmonary diseases
- Concurrent neurological diseases
- Communicative and/or cognitive problems affecting the ability to comprehend or follow instructions
- Other problems that affect the execution of the interventions, e.g. severe spasticity, contractures or dermatologic contraindications
Trial locations and contacts
1 site in 1 country.
Belgium1 site
St. Ursula Rehabilitation Centre (Jessa Hospital)
Herk-de-Stad, Limburg, 3540
About this study
The primary objective of the study is to investigate the energy consumption, cardiorespiratory load and perceived exertion, and how these parameters change, during walking with robot-assistance compared to walking on a treadmill and walking overground in stroke patients.
A secondary objective is to investigate whether these changes or differences in energy consumption, cardiorespiratory load and perceived exertion during walking with and without robot-assistance in stroke patients are related to changes or differences spatiotemporal gait characteristics.
Read the detailed description
Background. Impaired cardiorespiratory fitness, which is a major risk factor in the development of cardiorespiratory diseases, is frequently reported in stroke patients. The mean energy cost of walking, i.e. the amount of oxygen consumption in milliliter per kilogram of body-weight per meter, in stroke patients is almost twice as high compared to healthy subjects (resp. 0.27 ml/kg/m vs. 0.15 ml/kg/m). In the rehabilitation of stroke patients, the primary aim is to improve kinematic and functional gait-related parameters. However, due to the previously mentioned cardiorespiratory risks, it is important to be aware of the energy consumption and cardiorespiratory load of stroke patients during gait rehabilitation. In the past, gait training was mainly fulfilled by treadmill training, overground training and/or more conventional therapies, but in recent years, the implementation of robot-assistance in gait rehabilitation is increasing. However, what the influence is of robot-assistance on the cardiorespiratory load and energy consumption, and therefore also what potentially negative and/or positive side effects are for the cardiorespiratory system, is less investigated and unclear.
Up to now, short walking durations of robot-assisted gait (up to 7 minutes) seem less energy consuming and cardiorespiratory stressful than walking without robot-assistance. However, what the influences are of longer walking durations is not clear. In addition, it is also unclear why possible differences between robot-assisted gait and walking without robot-assistance might exist. One possible explanation might be that differences in spatiotemporal gait parameters are responsible for differences in energy consumption and cardiorespiratory load.
Patient recruitment. Stroke patients in the Rehabilitation Centre St. Ursula (Herk-de-Stad, Belgium) will receive verbal and written information on the aims and interventions of the study. Eligible stroke patients, who agree to participate in the study, will be recruited. Signed informed consent will be obtained from all participants.
Sample size. Sample size calculation is based on previous investigations indicating large effect sizes between the effect of robot-assisted gait compared to walking without robot-assistance on energy consumption and cardiorespiratory load (based on a systematic review submitted for peer-review). To detect a large effect size (f = 0.40) of robot-assisted gait compared to overground and treadmill gait on energy consumption, cardiorespiratory load and perceived fatigue, in a repeated measures within subjects design (3 walking conditions and 4 measurements), with a significance level of 5% and a power level of 80%, a sample size of 21 subjects is needed (G*Power 3.1 for Mac). Sample size is inflated up to 24 subjects, so each walking order will be performed the same number of times.
Intervention. Patients will be tested in 3 single walking sessions each on a separate day: walking in the Lokomat with 60% guidance force, walking on a treadmill and walking overground. Within subjects, all walking conditions will be performed at the same comfortable walking speed (CWS), with the same amount of body-weight support (BWS) (if necessary) during a total duration of maximum 30 minutes. The CWS (with a maximum of 3.2 kmph corresponding to the maximum Lokomat speed) and the amount of BWS (if necessary) will be individually determined on a separate day before the start of the study. Walking tests 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. Patients will be asked to not consume food, alcohol, caffeine or nicotine at least 3 hours prior to the intervention, and not to perform additional strenuous activities at least 12 hours prior to the interventions. Walking sessions will be controlled for time of day. Before the start of the study, demographic and clinical characteristics will be collected and the CWS and the amount of BWS (if necessary) will be determined in a 10 minute walking test. At the start of each walking condition, a chest-carrying gas analysis system with mouth mask (Metamax 3B, Cortex, Germany), a heart rate belt (Polar H7) and 2 wearable foot sensors (Physiolog, Gait Up, Switzerland) will be applied. Patients will be seated for 5 minutes during which resting values (energy consumption, cardiorespiratory parameters and perceived fatigue) will be registered. After a resting period of 5 minutes, patients will walk for 30 minutes during which energy consumption, cardiorespiratory parameters, perceived fatigue and spatiotemporal parameters will be monitored continuously. Perceived fatigue will be registered every minute. Average values at rest, the beginning, middle and end of the walking sessions will be calculated offline.
Randomization and Concealment. Walking sessions will be performed in a random order at 3 separate days. An independent investigator will assign the 24 patients (in 2 series of 12) at random to one of the 6 possible walking orders using a random sequence generator. Allocation will be concealed for the investigators using an excel file with blind and locked sections, to which only the independent investigator has access to. The random walking order of the patient will therefore only be available when the patient has been recruited and his name is entered in the excel sheet. This method will assure that the investigator does not know the walking order of the next participant.
Dropout. In case subjects drop out, the subject will be replaced by a new participant who will perform all three trials in the same randomized order as the subject that dropped out. So, in case of drop out, additional patients will be tested until the data of 24 patients that participated in all three conditions are collected.
Statistical analysis. Statistics will be performed using SPSS (IBM, Chicago, IL). Descriptive statistics will be calculated for baseline demographic and clinical patient characteristics. Repeated measures analyses of variance (ANOVA) with Bonferroni correction for multiple comparisons will be used to analyze differences in primary and secondary outcomes within and between walking conditions. Regression analysis will be performed to evaluate whether (changes in) spatiotemporal parameters are predictive for (changes in) energy consumption. The significance level will be set at 5%.
- Conditions
- Stroke
- Being tested
- Lokomat, Treadmill, Overground
- Keywords
- Robot-Assistance, Gait [MeSH], Energy Consumption, Cardiorespiratory Load, Stroke [MeSH]
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LokomatDevice
A single walking trial in which the patient walks in the Lokomat with 60% guidance force for 30 minutes at comfortable walking speed (body-weight supported if necessary)
TreadmillOther
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
OvergroundOther
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
| Study group | Role | What they receive |
|---|---|---|
| Lokomat - Treadmill - Overground | Experimental | Walking order: lokomat walking, treadmill walking, overground walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
| Lokomat - Overground - Treadmill | Experimental | Walking order: lokomat walking, overground walking, treadmill walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
| Treadmill - Lokomat - Overground | Experimental | Walking order: treadmill walking, lokomat walking, overground walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
| Treadmill - Overground - Lokomat | Experimental | Walking order: treadmill walking, overground walking, lokomat walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
| Overground - Lokomat - Treadmill | Experimental | Walking order: overground walking, lokomat walking, treadmill walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
| Overground - Treadmill - Lokomat | Experimental | Walking order: overground walking, treadmill walking, lokomat walking Receives: Device: Lokomat; Other: Treadmill; Other: Overground |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross oxygen consumption (VO2) at rest
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Measured: Minute 5 of 5-minute resting period
Gross oxygen consumption (VO2) at begin of walking
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Measured: Minute 6 of 30-minute walking period
Gross oxygen consumption (VO2) at mid of walking
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Measured: Minute 18 of 30-minute walking period
Gross oxygen consumption (VO2) at end of walking
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Measured: Minute 30 of 30-minute walking period
Net oxygen consumption (VO2)
Change in average oxygen consumption (mL/kg/min) at different time frames during walking compared to rest. VO2 will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Measured: Change between average VO2 at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Gross minute ventilation (VE) at rest
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 5 of 5-minute resting period
Gross minute ventilation (VE) at begin of walking
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 6 of 30-minute walking period
Gross minute ventilation (VE) at mid of walking
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 18 of 30-minute walking period
Gross minute ventilation (VE) at end of walking
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 30 of 30-minute walking period
Net minute ventilation (VE)
Change in average amount of air in- or exhaled (L/min) at different time frames during walking compared to rest. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Change between average VE at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Gross respiration rate (RR) at rest
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 5 of 5-minute resting period
Gross respiration rate (RR) at begin of walking
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 6 of 30-minute walking period
Gross respiration rate (RR) at mid of walking
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 18 of 30-minute walking period
Gross respiration rate (RR) at end of walking
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 30 of 30-minute walking period
Net respiration rate (RR)
Change in respiration rate (breaths per minute) at different time frames during walking compared to rest. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Change between average respiration rate at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Gross heart rate (HR) at rest
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 5 of 5-minute resting period
Gross heart rate (HR) at begin of walking
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 6 of 30-minute walking period
Gross heart rate (HR) at mid of walking
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 18 of 30-minute walking period
Gross heart rate (HR) at end of walking
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Minute 30 of 30-minute walking period
Net heart rate (HR)
Change in average heart rate (beats/min) at different time frames during walking compared to rest. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Change between average heart rate at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Gross Respiratory Exchange Ratio (RER) at rest
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Measured: Minute 5 of 5-minute resting period
Gross Respiratory Exchange Ratio (RER) at begin of walking
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Measured: Minute 6 of 30-minute walking period
Gross Respiratory Exchange Ratio (RER) at mid of walking
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Measured: Minute 18 of 30-minute walking period
Gross Respiratory Exchange Ratio (RER) at end of walking
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Measured: Minute 30 of 30-minute walking period
Net Respiratory Exchange Ratio (RER)
Change in RER at different time frames during walking compared to rest. RER will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Measured: Change between average RER at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Metabolic Equivalent of Task (MET) at begin of walking
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Measured: Minute 6 of 30-minute walking period
Metabolic Equivalent of Task (MET) at mid of walking
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Measured: Minute 18 of 30-minute walking period
Metabolic Equivalent of Task (MET) at end of walking
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards
Measured: Minute 30 of 30-minute walking period
Secondary outcomes (6)
Gross perceived exertion (assessed by the 6-20 Borg scale) at rest
Rating of perceived effort, strain and/or fatigue pointed on a 15-point Borg scale (6-20). Borg score will be measured at the end of rest (min 5) and at the end of every minute of walking.
Measured: Minute 5 of 5-minute resting period
Gross perceived exertion (assessed by the 6-20 Borg scale) at begin of walking
Rating of perceived effort, strain and/or fatigue pointed on a 15-point Borg scale (6-20). Borg score will be measured at the end of rest (min 5) and at the end of every minute of walking.
Measured: Minute 6 of 30-minute walking period
Gross perceived exertion (assessed by the 6-20 Borg scale) at mid of walking
Rating of perceived effort, strain and/or fatigue pointed on a 15-point Borg scale (6-20). Borg score will be measured at the end of rest (min 5) and at the end of every minute of walking.
Measured: Minute 18 of 30-minute walking period
Gross perceived exertion (assessed by the 6-20 Borg scale) at end of walking
Rating of perceived effort, strain and/or fatigue pointed on a 15-point Borg scale (6-20). Borg score will be measured at the end of rest (min 5) and at the end of every minute of walking.
Measured: Minute 30 of 30-minute walking period
Net perceived exertion (assessed by the 6-20 Borg scale)
Change in Borg score at different time frames during walking compared to rest. Borg score will be measured at the end of rest (min 5) and at the end of every minute of walking.
Measured: Change between Borg score at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Total walking duration
Total walking duration the patient can achieve in a single walking session (with a maximum of 30 minutes)
Measured: Begin till end of walking (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Difficulties patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Lefeber, Vrije Universiteit Brussel
- Investigators
- Eric Kerckhofs, Prof. PhD, Study chair, Vrije Universiteit BrusselEva Swinnen, PhD, Study director, Vrije Universiteit BrusselNina Lefeber, PhD student, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680496
- Sponsor's protocol ID
- LOKOMAT STUDY I
- Other IDs
- SBO-IWT MIRAD project, SBO doctoral grant
- Status last verified
- Nov 2017
- First submitted
- 27 Jan 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
Publications
Myers J, McAuley P, Lavie CJ, Despres JP, Arena R, Kokkinos P. Physical activity and cardiorespiratory fitness as major markers of cardiovascular risk: their independent and interwoven importance to health status. Prog Cardiovasc Dis. 2015 Jan-Feb;57(4):306-14. doi: 10.1016/j.pcad.2014.09.011. Epub 2014 Sep 28.
PubMed 25269064Kelly JO, Kilbreath SL, Davis GM, Zeman B, Raymond J. Cardiorespiratory fitness and walking ability in subacute stroke patients. Arch Phys Med Rehabil. 2003 Dec;84(12):1780-5. doi: 10.1016/s0003-9993(03)00376-9.
PubMed 14669183Smith AC, Saunders DH, Mead G. Cardiorespiratory fitness after stroke: a systematic review. Int J Stroke. 2012 Aug;7(6):499-510. doi: 10.1111/j.1747-4949.2012.00791.x. Epub 2012 May 9.
PubMed 22568786Waters RL, Mulroy S. The energy expenditure of normal and pathologic gait. Gait Posture. 1999 Jul;9(3):207-31. doi: 10.1016/s0966-6362(99)00009-0.
PubMed 10575082Mehrholz J, Pohl M, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2014 Jan 23;2014(1):CD002840. doi: 10.1002/14651858.CD002840.pub3.
PubMed 24458944States RA, Salem Y, Pappas E. Overground gait training for individuals with chronic stroke: a Cochrane systematic review. J Neurol Phys Ther. 2009 Dec;33(4):179-86. doi: 10.1097/NPT.0b013e3181c29a8c.
PubMed 20208461Swinnen E, Duerinck S, Baeyens JP, Meeusen R, Kerckhofs E. Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):520-6. doi: 10.2340/16501977-0538.
PubMed 20549155Swinnen E, Beckwee D, Pinte D, Meeusen R, Baeyens JP, Kerckhofs E. Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Mult Scler Int. 2012;2012:240274. doi: 10.1155/2012/240274. Epub 2012 May 30.
PubMed 22701177Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013 Jul 25;2013(7):CD006185. doi: 10.1002/14651858.CD006185.pub3.
PubMed 23888479Ada L, Dean CM, Vargas J, Ennis S. Mechanically assisted walking with body weight support results in more independent walking than assisted overground walking in non-ambulatory patients early after stroke: a systematic review. J Physiother. 2010;56(3):153-61. doi: 10.1016/s1836-9553(10)70020-5.
PubMed 20795921David D, Regnaux JP, Lejaille M, Louis A, Bussel B, Lofaso F. Oxygen consumption during machine-assisted and unassisted walking: a pilot study in hemiplegic and healthy humans. Arch Phys Med Rehabil. 2006 Apr;87(4):482-9. doi: 10.1016/j.apmr.2005.11.034.
PubMed 16571386Delussu AS, Morone G, Iosa M, Bragoni M, Traballesi M, Paolucci S. Physiological responses and energy cost of walking on the Gait Trainer with and without body weight support in subacute stroke patients. J Neuroeng Rehabil. 2014 Apr 10;11:54. doi: 10.1186/1743-0003-11-54.
PubMed 24720844Farris RJ, Quintero HA, Murray SA, Ha KH, Hartigan C, Goldfarb M. A preliminary assessment of legged mobility provided by a lower limb exoskeleton for persons with paraplegia. IEEE Trans Neural Syst Rehabil Eng. 2014 May;22(3):482-90. doi: 10.1109/TNSRE.2013.2268320. Epub 2013 Jun 18.
PubMed 23797285Fenuta AM, Hicks AL. Metabolic demand and muscle activation during different forms of bodyweight supported locomotion in men with incomplete SCI. Biomed Res Int. 2014;2014:632765. doi: 10.1155/2014/632765. Epub 2014 May 21.
PubMed 24971340Kitatani R, Ohata K, Takahashi H, Shibuta S, Hashiguchi Y, Yamakami N. Reduction in energy expenditure during walking using an automated stride assistance device in healthy young adults. Arch Phys Med Rehabil. 2014 Nov;95(11):2128-33. doi: 10.1016/j.apmr.2014.07.008. Epub 2014 Jul 24.
PubMed 25064779
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Consumption and Cardiorespiratory Load During Walking With and Without Robot-Assistance
- ClinicalTrials.gov ID
- NCT02680496
- Acronym / sponsor ID
- LOKOMAT STUDY I
- Conditions
- Stroke
- Keywords
- Robot-Assistance, Gait [MeSH], Energy Consumption, Cardiorespiratory Load, Stroke [MeSH]
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties patient recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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.
The primary objective of the study is to investigate the energy consumption, cardiorespiratory load and perceived exertion, and how these parameters change, during walking with robot-assistance compared to walking on a treadmill and walking overground in stroke patients.
A secondary objective is to investigate whether these changes or differences in energy consumption, cardiorespiratory load and perceived exertion during walking with and without robot-assistance in stroke patients are related to changes or differences spatiotemporal gait characteristics.
Detailed description
Background. Impaired cardiorespiratory fitness, which is a major risk factor in the development of cardiorespiratory diseases, is frequently reported in stroke patients. The mean energy cost of walking, i.e. the amount of oxygen consumption in milliliter per kilogram of body-weight per meter, in stroke patients is almost twice as high compared to healthy subjects (resp. 0.27 ml/kg/m vs. 0.15 ml/kg/m). In the rehabilitation of stroke patients, the primary aim is to improve kinematic and functional gait-related parameters. However, due to the previously mentioned cardiorespiratory risks, it is important to be aware of the energy consumption and cardiorespiratory load of stroke patients during gait rehabilitation. In the past, gait training was mainly fulfilled by treadmill training, overground training and/or more conventional therapies, but in recent years, the implementation of robot-assistance in gait rehabilitation is increasing. However, what the influence is of robot-assistance on the cardiorespiratory load and energy consumption, and therefore also what potentially negative and/or positive side effects are for the cardiorespiratory system, is less investigated and unclear.
Up to now, short walking durations of robot-assisted gait (up to 7 minutes) seem less energy consuming and cardiorespiratory stressful than walking without robot-assistance. However, what the influences are of longer walking durations is not clear. In addition, it is also unclear why possible differences between robot-assisted gait and walking without robot-assistance might exist. One possible explanation might be that differences in spatiotemporal gait parameters are responsible for differences in energy consumption and cardiorespiratory load.
Patient recruitment. Stroke patients in the Rehabilitation Centre St. Ursula (Herk-de-Stad, Belgium) will receive verbal and written information on the aims and interventions of the study. Eligible stroke patients, who agree to participate in the study, will be recruited. Signed informed consent will be obtained from all participants.
Sample size. Sample size calculation is based on previous investigations indicating large effect sizes between the effect of robot-assisted gait compared to walking without robot-assistance on energy consumption and cardiorespiratory load (based on a systematic review submitted for peer-review). To detect a large effect size (f = 0.40) of robot-assisted gait compared to overground and treadmill gait on energy consumption, cardiorespiratory load and perceived fatigue, in a repeated measures within subjects design (3 walking conditions and 4 measurements), with a significance level of 5% and a power level of 80%, a sample size of 21 subjects is needed (G*Power 3.1 for Mac). Sample size is inflated up to 24 subjects, so each walking order will be performed the same number of times.
Intervention. Patients will be tested in 3 single walking sessions each on a separate day: walking in the Lokomat with 60% guidance force, walking on a treadmill and walking overground. Within subjects, all walking conditions will be performed at the same comfortable walking speed (CWS), with the same amount of body-weight support (BWS) (if necessary) during a total duration of maximum 30 minutes. The CWS (with a maximum of 3.2 kmph corresponding to the maximum Lokomat speed) and the amount of BWS (if necessary) will be individually determined on a separate day before the start of the study. Walking tests 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. Patients will be asked to not consume food, alcohol, caffeine or nicotine at least 3 hours prior to the intervention, and not to perform additional strenuous activities at least 12 hours prior to the interventions. Walking sessions will be controlled for time of day. Before the start of the study, demographic and clinical characteristics will be collected and the CWS and the amount of BWS (if necessary) will be determined in a 10 minute walking test. At the start of each walking condition, a chest-carrying gas analysis system with mouth mask (Metamax 3B, Cortex, Germany), a heart rate belt (Polar H7) and 2 wearable foot sensors (Physiolog, Gait Up, Switzerland) will be applied. Patients will be seated for 5 minutes during which resting values (energy consumption, cardiorespiratory parameters and perceived fatigue) will be registered. After a resting period of 5 minutes, patients will walk for 30 minutes during which energy consumption, cardiorespiratory parameters, perceived fatigue and spatiotemporal parameters will be monitored continuously. Perceived fatigue will be registered every minute. Average values at rest, the beginning, middle and end of the walking sessions will be calculated offline.
Randomization and Concealment. Walking sessions will be performed in a random order at 3 separate days. An independent investigator will assign the 24 patients (in 2 series of 12) at random to one of the 6 possible walking orders using a random sequence generator. Allocation will be concealed for the investigators using an excel file with blind and locked sections, to which only the independent investigator has access to. The random walking order of the patient will therefore only be available when the patient has been recruited and his name is entered in the excel sheet. This method will assure that the investigator does not know the walking order of the next participant.
Dropout. In case subjects drop out, the subject will be replaced by a new participant who will perform all three trials in the same randomized order as the subject that dropped out. So, in case of drop out, additional patients will be tested until the data of 24 patients that participated in all three conditions are collected.
Statistical analysis. Statistics will be performed using SPSS (IBM, Chicago, IL). Descriptive statistics will be calculated for baseline demographic and clinical patient characteristics. Repeated measures analyses of variance (ANOVA) with Bonferroni correction for multiple comparisons will be used to analyze differences in primary and secondary outcomes within and between walking conditions. Regression analysis will be performed to evaluate whether (changes in) spatiotemporal parameters are predictive for (changes in) energy consumption. The significance level will be set at 5%.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lokomat - Treadmill - Overground | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: lokomat walking, treadmill walking, overground walking |
| Lokomat - Overground - Treadmill | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: lokomat walking, overground walking, treadmill walking |
| Treadmill - Lokomat - Overground | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: treadmill walking, lokomat walking, overground walking |
| Treadmill - Overground - Lokomat | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: treadmill walking, overground walking, lokomat walking |
| Overground - Lokomat - Treadmill | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: overground walking, lokomat walking, treadmill walking |
| Overground - Treadmill - Lokomat | Experimental | Device: Lokomat, Other: Treadmill, Other: OvergroundWalking order: overground walking, treadmill walking, lokomat walking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke patients with a lower limb motor impairment
- Time since stroke < 1 year
- ≥ 18 years
- < 193 cm
- < 135kg
Key exclusion criteria (6 listed)
- Contra-indications for exercise testing according to the American College of Sports Medicine
- Musculoskeletal problems (other than stroke) affecting the ability to walk
- Concurrent pulmonary diseases
- Concurrent neurological diseases
- Communicative and/or cognitive problems affecting the ability to comprehend or follow instructions
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 |
|---|---|---|
| LokomatA single walking trial in which the patient walks in the Lokomat with 60% guidance force for 30 minutes at comfortable walking speed (body-weight supported if necessary) | Device | Lokomat - Overground - Treadmill, Lokomat - Treadmill - Overground, Overground - Lokomat - Treadmill, Overground - Treadmill - Lokomat, Treadmill - Lokomat - Overground, Treadmill - Overground - Lokomat |
| TreadmillA single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary) | Other | Lokomat - Overground - Treadmill, Lokomat - Treadmill - Overground, Overground - Lokomat - Treadmill, Overground - Treadmill - Lokomat, Treadmill - Lokomat - Overground, Treadmill - Overground - Lokomat |
| OvergroundA single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary) | Other | Lokomat - Overground - Treadmill, Lokomat - Treadmill - Overground, Overground - Lokomat - Treadmill, Overground - Treadmill - Lokomat, Treadmill - Lokomat - Overground, Treadmill - Overground - Lokomat |
Primary outcome
Gross oxygen consumption (VO2) at rest
Time frame: Minute 5 of 5-minute resting period
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Gross oxygen consumption (VO2) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Gross oxygen consumption (VO2) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Gross oxygen consumption (VO2) at end of walking
Time frame: Minute 30 of 30-minute walking period
Average oxygen consumption (mL/kg/min). Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Net oxygen consumption (VO2)
Time frame: Change between average VO2 at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Change in average oxygen consumption (mL/kg/min) at different time frames during walking compared to rest. VO2 will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Gross minute ventilation (VE) at rest
Time frame: Minute 5 of 5-minute resting period
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross minute ventilation (VE) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross minute ventilation (VE) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross minute ventilation (VE) at end of walking
Time frame: Minute 30 of 30-minute walking period
Average amount of air in- or exhaled (L/min). VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Net minute ventilation (VE)
Time frame: Change between average VE at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Change in average amount of air in- or exhaled (L/min) at different time frames during walking compared to rest. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross respiration rate (RR) at rest
Time frame: Minute 5 of 5-minute resting period
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross respiration rate (RR) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross respiration rate (RR) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross respiration rate (RR) at end of walking
Time frame: Minute 30 of 30-minute walking period
Average breaths per minute. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Net respiration rate (RR)
Time frame: Change between average respiration rate at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Change in respiration rate (breaths per minute) at different time frames during walking compared to rest. Respiration rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross heart rate (HR) at rest
Time frame: Minute 5 of 5-minute resting period
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross heart rate (HR) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross heart rate (HR) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross heart rate (HR) at end of walking
Time frame: Minute 30 of 30-minute walking period
Average heart rate (beats/min). Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Net heart rate (HR)
Time frame: Change between average heart rate at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Change in average heart rate (beats/min) at different time frames during walking compared to rest. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Gross Respiratory Exchange Ratio (RER) at rest
Time frame: Minute 5 of 5-minute resting period
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Gross Respiratory Exchange Ratio (RER) at begin of walking
Time frame: Minute 6 of 30-minute walking period
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Gross Respiratory Exchange Ratio (RER) at mid of walking
Time frame: Minute 18 of 30-minute walking period
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Gross Respiratory Exchange Ratio (RER) at end of walking
Time frame: Minute 30 of 30-minute walking period
RER is the ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body (VCO2/VO2). This ratio gives an indication of the type of fuel used to produce ATP.
Net Respiratory Exchange Ratio (RER)
Time frame: Change between average RER at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Change in RER at different time frames during walking compared to rest. RER will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Metabolic Equivalent of Task (MET) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Metabolic Equivalent of Task (MET) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards.
Metabolic Equivalent of Task (MET) at end of walking
Time frame: Minute 30 of 30-minute walking period
Expression of the intensity of physical activity (at different time frames) defined as oxygen consumption during walking divided by reference oxygen consumption in rest. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations will be performed afterwards
6 secondary outcomes
Gross perceived exertion (assessed by the 6-20 Borg scale) at rest
Time frame: Minute 5 of 5-minute resting period
Gross perceived exertion (assessed by the 6-20 Borg scale) at begin of walking
Time frame: Minute 6 of 30-minute walking period
Gross perceived exertion (assessed by the 6-20 Borg scale) at mid of walking
Time frame: Minute 18 of 30-minute walking period
Gross perceived exertion (assessed by the 6-20 Borg scale) at end of walking
Time frame: Minute 30 of 30-minute walking period
Net perceived exertion (assessed by the 6-20 Borg scale)
Time frame: Change between Borg score at minute 5 of rest and minute 6 of walking, at minute 5 of rest and minute 18 of walking, at minute 5 of rest and minute 30 of walking
Total walking duration
Time frame: Begin till end of walking (up to 30 minutes)
Results and safety
The study was stopped early (reason given: Difficulties patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 25269064Myers J, McAuley P, Lavie CJ, Despres JP, Arena R, Kokkinos P. Physical activity and cardiorespiratory fitness as major markers of cardiovascular risk: their independent and interwoven importance to health status. Prog Cardiovasc Dis. 2015 Jan-Feb;57(4):306-14. doi: 10.1016/j.pcad.2014.09.011. Epub 2014 Sep 28.
- Background: PubMed 14669183Kelly JO, Kilbreath SL, Davis GM, Zeman B, Raymond J. Cardiorespiratory fitness and walking ability in subacute stroke patients. Arch Phys Med Rehabil. 2003 Dec;84(12):1780-5. doi: 10.1016/s0003-9993(03)00376-9.
- Background: PubMed 22568786Smith AC, Saunders DH, Mead G. Cardiorespiratory fitness after stroke: a systematic review. Int J Stroke. 2012 Aug;7(6):499-510. doi: 10.1111/j.1747-4949.2012.00791.x. Epub 2012 May 9.
- Background: PubMed 10575082Waters RL, Mulroy S. The energy expenditure of normal and pathologic gait. Gait Posture. 1999 Jul;9(3):207-31. doi: 10.1016/s0966-6362(99)00009-0.
- Background: PubMed 24458944Mehrholz J, Pohl M, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2014 Jan 23;2014(1):CD002840. doi: 10.1002/14651858.CD002840.pub3.
- Background: PubMed 20208461States RA, Salem Y, Pappas E. Overground gait training for individuals with chronic stroke: a Cochrane systematic review. J Neurol Phys Ther. 2009 Dec;33(4):179-86. doi: 10.1097/NPT.0b013e3181c29a8c.
- Background: PubMed 20549155Swinnen E, Duerinck S, Baeyens JP, Meeusen R, Kerckhofs E. Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):520-6. doi: 10.2340/16501977-0538.
- Background: PubMed 22701177Swinnen E, Beckwee D, Pinte D, Meeusen R, Baeyens JP, Kerckhofs E. Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Mult Scler Int. 2012;2012:240274. doi: 10.1155/2012/240274. Epub 2012 May 30.
- Background: PubMed 23888479Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013 Jul 25;2013(7):CD006185. doi: 10.1002/14651858.CD006185.pub3.
- Background: PubMed 20795921Ada L, Dean CM, Vargas J, Ennis S. Mechanically assisted walking with body weight support results in more independent walking than assisted overground walking in non-ambulatory patients early after stroke: a systematic review. J Physiother. 2010;56(3):153-61. doi: 10.1016/s1836-9553(10)70020-5.
- Background: PubMed 16571386David D, Regnaux JP, Lejaille M, Louis A, Bussel B, Lofaso F. Oxygen consumption during machine-assisted and unassisted walking: a pilot study in hemiplegic and healthy humans. Arch Phys Med Rehabil. 2006 Apr;87(4):482-9. doi: 10.1016/j.apmr.2005.11.034.
- Background: PubMed 24720844Delussu AS, Morone G, Iosa M, Bragoni M, Traballesi M, Paolucci S. Physiological responses and energy cost of walking on the Gait Trainer with and without body weight support in subacute stroke patients. J Neuroeng Rehabil. 2014 Apr 10;11:54. doi: 10.1186/1743-0003-11-54.
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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, 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 Lokomat, Treadmill and Overground 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?
The sponsor lists 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Dec 2017. 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: Difficulties patient recruitment). 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?
Gross oxygen consumption (VO2) at rest (time frame: Minute 5 of 5-minute resting period). The study lists 28 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 NCT02680496, which also lists 23 linked publications.
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 2 Dec 2017.