NCT02680496

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

January 27, 2016

Last Update Submit

November 30, 2017

Conditions

Stroke

Keywords

Robot-AssistanceGait [MeSH]Energy ConsumptionCardiorespiratory LoadStroke [MeSH]

Outcome Measures

Primary Outcomes (28)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    Minute 30 of 30-minute walking period

Secondary Outcomes (6)

  • Gross perceived exertion (assessed by the 6-20 Borg scale) at rest

    Minute 5 of 5-minute resting period

  • Gross perceived exertion (assessed by the 6-20 Borg scale) at begin of walking

    Minute 6 of 30-minute walking period

  • Gross perceived exertion (assessed by the 6-20 Borg scale) at mid of walking

    Minute 18 of 30-minute walking period

  • Gross perceived exertion (assessed by the 6-20 Borg scale) at end of walking

    Minute 30 of 30-minute walking period

  • Net perceived exertion (assessed by the 6-20 Borg scale)

    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

  • +1 more secondary outcomes

Other Outcomes (27)

  • Paretic cadence

    Minute 6, 18 and 30 of 30-minute walking period

  • Non-paretic cadence

    Minute 6, 18 and 30 of 30-minute walking period

  • Cadence symmetry ratio

    Minute 6, 18 and 30 of 30-minute walking period

  • +24 more other outcomes

Study Arms (6)

Lokomat - Treadmill - Overground

EXPERIMENTAL

Walking order: lokomat walking, treadmill walking, overground walking

Device: LokomatOther: TreadmillOther: Overground

Lokomat - Overground - Treadmill

EXPERIMENTAL

Walking order: lokomat walking, overground walking, treadmill walking

Device: LokomatOther: TreadmillOther: Overground

Treadmill - Lokomat - Overground

EXPERIMENTAL

Walking order: treadmill walking, lokomat walking, overground walking

Device: LokomatOther: TreadmillOther: Overground

Treadmill - Overground - Lokomat

EXPERIMENTAL

Walking order: treadmill walking, overground walking, lokomat walking

Device: LokomatOther: TreadmillOther: Overground

Overground - Lokomat - Treadmill

EXPERIMENTAL

Walking order: overground walking, lokomat walking, treadmill walking

Device: LokomatOther: TreadmillOther: Overground

Overground - Treadmill - Lokomat

EXPERIMENTAL

Walking order: overground walking, treadmill walking, lokomat walking

Device: LokomatOther: TreadmillOther: Overground

Interventions

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)

Lokomat - Overground - TreadmillLokomat - Treadmill - OvergroundOverground - Lokomat - TreadmillOverground - Treadmill - LokomatTreadmill - Lokomat - OvergroundTreadmill - Overground - Lokomat
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)

Lokomat - Overground - TreadmillLokomat - Treadmill - OvergroundOverground - Lokomat - TreadmillOverground - Treadmill - LokomatTreadmill - Lokomat - OvergroundTreadmill - Overground - Lokomat
OvergroundOTHER

A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)

Lokomat - Overground - TreadmillLokomat - Treadmill - OvergroundOverground - Lokomat - TreadmillOverground - Treadmill - LokomatTreadmill - Lokomat - OvergroundTreadmill - Overground - Lokomat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Ursula Rehabilitation Centre (Jessa Hospital)

Herk-de-Stad, Limburg, 3540, Belgium

Location

Related Publications (23)

  • 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.

    PMID: 25269064BACKGROUND

  • 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.

    PMID: 14669183BACKGROUND

  • 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.

    PMID: 22568786BACKGROUND

  • Waters 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.

    PMID: 10575082BACKGROUND

  • 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.

    PMID: 24458944BACKGROUND

  • States 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.

    PMID: 20208461BACKGROUND

  • 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.

    PMID: 20549155BACKGROUND

  • 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.

    PMID: 22701177BACKGROUND

  • 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.

    PMID: 23888479BACKGROUND

  • 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.

    PMID: 20795921BACKGROUND

  • 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.

    PMID: 16571386BACKGROUND

  • 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.

    PMID: 24720844BACKGROUND

  • Farris 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.

    PMID: 23797285BACKGROUND

  • 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.

    PMID: 24971340BACKGROUND

  • 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.

    PMID: 25064779BACKGROUND

  • 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.

    PMID: 21943320BACKGROUND

  • 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.

    PMID: 23418524BACKGROUND

  • 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.

    PMID: 23516057BACKGROUND

  • 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.

    PMID: 17079746BACKGROUND

  • 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.

    PMID: 22700537BACKGROUND

  • 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.

    PMID: 17113774BACKGROUND

  • 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.

    PMID: 23877260BACKGROUND

  • Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.

    PMID: 19932621BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Eric Kerckhofs, Prof. PhD

    Vrije Universiteit Brussel

    STUDY CHAIR

  • Eva Swinnen, PhD

    Vrije Universiteit Brussel

    STUDY DIRECTOR

  • Nina Lefeber, PhD student

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

BE(1)