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Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients

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ClinicalTrials.gov Identifier: NCT02995616
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Lefeber, Vrije Universiteit Brussel

Brief Summary:

The aim of this study will be to investigate the energy consumption, cardiorespiratory load and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted gait training (RAGT) session and to compare the exercise intensity with aerobic training recommendations.

The second aim is to investigate the effect of different levels of guidance force on the energy consumption, cardiorespiratory load and perceived exertion.


Condition or disease Intervention/treatment Phase
Stroke Device: Regular therapy settings Device: 100% guidance force Device: 60% guidance force Not Applicable

Detailed Description:

STUDY DESIGN. An experimental, 1-group, single-centre trial will be conducted in which stroke patients will perform 2 RAGT sessions: 1) walking in the Lokomat according to regular RAGT settings and 2) walking in the Lokomat with different levels of guidance force (60%, 80% and 100%).

PATIENT RECRUITMENT. We aim to recruit 20 stroke patients in the St. Ursula Rehabilitation Centre in Herk-de-Stad, Belgium.

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

PROCEDURE. Patients will be tested in 3 RAGT sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed). During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (once 60% and once 100%) for a minimum 20 minutes each and with the same amount of body weight support and walking speed as in the first session. On a separate day before the intervention, patients will be seated for 10 minutes during which resting values (respiratory gases and heart rate) will be assessed (in order to measure their Resting Metabolic Rate). In addition, informed consent and baseline clinical demographic characteristics will be obtained. At the start of the intervention, a mouth mask, heart rate monitor and gait analysis system will be applied. After a seated resting period of 5 minutes, patients will walk for a minimum of 20 minutes during which respiratory gases and heart rate will be monitored continuously. The Borg rating of perceived exertion will be registered every 3 minutes. The intervention will be terminated early when relative or absolute indications are presented as reported by the American Heart Association or when patients are unable to continue walking. Walking sessions will be controlled for time of day.

RANDOMIZATION. The levels of GF will be randomised..

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

STATISTICAL ANALYSIS. Statistics will be performed using SPSS (IBM, Chicago, IL). The significance level will be set at 5%. Descriptive statistics will be calculated for baseline patient characteristics. Means and standard deviations will be calculated for continuous variables and frequencies and percentages for categorical variables. To investigate the effect of time and the effect of different levels of guidance force, repeated measures ANOVAs (within subject factors) will be analyzed. In case of significant differences, posthoc analysis will be interpreted. To investigate if the effect of guidance force is related to the patient's baseline level of GF (i.e. GF during regular therapy settings) correlational analysis will be performed and baseline GF will be considered as a covariate.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients
Actual Study Start Date : March 16, 2017
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Arm Intervention/treatment
Experimental: Lokomat training
Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).
Device: Regular therapy settings
Patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed)

Device: 100% guidance force
Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)

Device: 60% guidance force
Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)




Primary Outcome Measures :
  1. Oxygen consumption (VO2) [ Time Frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) ]
    Average oxygen consumption (mL/kg/min) at different time frames. 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.

  2. Carbon Dioxide Production (CO2) [ Time Frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) ]
    Average carbon dioxide production (mL/kg/min) at different time frames. Carbon dioxide production will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.

  3. Minute ventilation (VE) [ Time Frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) ]
    Average amount of air in- or exhaled (L/min) at different time frames. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.

  4. Heart rate (HR) [ Time Frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) ]
    Average heart rate (beats/min) at different time frames. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.

  5. Percentage heart rate reserve (%HRR) [ Time Frame: Begin, mid and end of 20min walking period (session 1) ]
    The percentage of the heart rate reserve (i.e. the difference between the person's predicted maximum heart rate and the person's resting heart rate) at different time moments (= heart rate at different times moments divided by predicted heart rate reserve).

  6. Percentage maximal heart rate (%HRmax) [ Time Frame: Begin, mid and end of 20min walking period (session 1) ]
    The percentage of the person's predicted maximal heart rate at different time moments (= heart rate at different times moments divided by predicted maximal heart rate).

  7. Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE) [ Time Frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) ]
    Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) at the end of rest and during walking (every 3 minutes).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First-ever subacute (≤ 3 months) stroke patients
  • Eligible to receive robot-assisted gait training according to local therapists' criteria (i.e. non-ambulatory stroke patients that are able to bear full weight on the hemiplegic leg during a minimum of one gait cycle with manual help allowed to maintain balance)
  • Functional Ambulation Category < 3
  • Trained in the Lokomat system 2 times prior to the start of the study (i.e. one fitting session and one training session).

Exclusion Criteria:

  • > 135 kg and >179 cm
  • Unstable cardiovascular conditions
  • Musculoskeletal problems (other than stroke) affecting the ability to walk
  • Concurrent pulmonary diseases (e.g. asthma)
  • Concurrent neurological diseases
  • Communicative and/or cognitive problems affecting the ability to comprehend or follow instructions
  • Other problems affecting the execution of the intervention (e.g. severe spasticity, contractures or dermatological contra-indications)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995616


Locations
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Belgium
St. Ursula Rehabilitation Centre (Jessa Hospital)
Herk-de-Stad, Limburg, Belgium, 3540
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
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Study Chair: Eric Kerckhofs, Prof. Ph.D Vrije Universiteit Brussel
Study Director: Eva Swinnen, Prof. Ph.D Vrije Universiteit Brussel
Principal Investigator: Nina Lefeber, Ph.D student Vrije Universiteit Brussel

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Responsible Party: Nina Lefeber, Doctoral Researcher, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT02995616     History of Changes
Other Study ID Numbers: LOKOMAT STUDY II
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nina Lefeber, Vrije Universiteit Brussel:
Robot-Assisted Gait Training
Guidance force
Stroke
Energy Consumption
Cardiorespiratory Load

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases