Energy Consumption and Cardiorespiratory Load During Walking With and Without Robot-Assistance
NCT ID: NCT02680496
Last Updated: 2017-12-02
Study Results
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Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2016-02-29
2017-08-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Lokomat - Treadmill - Overground
Walking order: lokomat walking, treadmill walking, overground walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Lokomat - Overground - Treadmill
Walking order: lokomat walking, overground walking, treadmill walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Treadmill - Lokomat - Overground
Walking order: treadmill walking, lokomat walking, overground walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Treadmill - Overground - Lokomat
Walking order: treadmill walking, overground walking, lokomat walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground - Lokomat - Treadmill
Walking order: overground walking, lokomat walking, treadmill walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground - Treadmill - Lokomat
Walking order: overground walking, treadmill walking, lokomat walking
Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Interventions
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Lokomat
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)
Treadmill
A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Overground
A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Responsible Party
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Nina Lefeber
PhD student
Principal Investigators
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Eric Kerckhofs, Prof. PhD
Role: STUDY_CHAIR
Vrije Universiteit Brussel
Eva Swinnen, PhD
Role: STUDY_DIRECTOR
Vrije Universiteit Brussel
Nina Lefeber, PhD student
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Locations
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St. Ursula Rehabilitation Centre (Jessa Hospital)
Herk-de-Stad, Limburg, Belgium
Countries
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References
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Kelly 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.
Smith 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.
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Mehrholz 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.
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Swinnen 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.
Swinnen 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.
Mehrholz 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.
Ada 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.
David 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.
Delussu 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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Fenuta 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.
Kitatani 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.
Maeshima S, Osawa A, Nishio D, Hirano Y, Takeda K, Kigawa H, Sankai Y. Efficacy of a hybrid assistive limb in post-stroke hemiplegic patients: a preliminary report. BMC Neurol. 2011 Sep 27;11:116. doi: 10.1186/1471-2377-11-116.
Malcolm P, Derave W, Galle S, De Clercq D. A simple exoskeleton that assists plantarflexion can reduce the metabolic cost of human walking. PLoS One. 2013;8(2):e56137. doi: 10.1371/journal.pone.0056137. Epub 2013 Feb 13.
van Nunen MP, Gerrits KH, de Haan A, Janssen TW. Exercise intensity of robot-assisted walking versus overground walking in nonambulatory stroke patients. J Rehabil Res Dev. 2012;49(10):1537-46. doi: 10.1682/jrrd.2011.12.0252.
Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. doi: 10.2522/ptj.20050266.
Hornby TG, Kinnaird CR, Holleran CL, Rafferty MR, Rodriguez KS, Cain JB. Kinematic, muscular, and metabolic responses during exoskeletal-, elliptical-, or therapist-assisted stepping in people with incomplete spinal cord injury. Phys Ther. 2012 Oct;92(10):1278-91. doi: 10.2522/ptj.20110310. Epub 2012 Jun 14.
Krewer C, Muller F, Husemann B, Heller S, Quintern J, Koenig E. The influence of different Lokomat walking conditions on the energy expenditure of hemiparetic patients and healthy subjects. Gait Posture. 2007 Sep;26(3):372-7. doi: 10.1016/j.gaitpost.2006.10.003. Epub 2006 Nov 20.
Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
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Other Identifiers
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SBO-IWT MIRAD project
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SBO doctoral grant
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LOKOMAT STUDY I
Identifier Type: -
Identifier Source: org_study_id