Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
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ClinicalTrials.gov Identifier: NCT01679600 |
Recruitment Status
:
Completed
First Posted
: September 6, 2012
Results First Posted
: August 5, 2015
Last Update Posted
: August 5, 2015
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Sponsor:
Bern University of Applied Sciences
Collaborators:
Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Oliver Stoller, Bern University of Applied Sciences
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | August 29, 2012 | ||||||||||||
First Posted Date ICMJE | September 6, 2012 | ||||||||||||
Results First Submitted Date | July 3, 2015 | ||||||||||||
Results First Posted Date | August 5, 2015 | ||||||||||||
Last Update Posted Date | August 5, 2015 | ||||||||||||
Study Start Date ICMJE | August 2012 | ||||||||||||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Peak Oxygen Uptake (V'O2peak) [ Time Frame: 4 weeks ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Aerobic capacity [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ] Peak oxygen uptake (VO2peak), peak work rate (WRpeak), peak heart rate (HRpeak), peak expiratory volume (VEpeak), peak respiratory exchange ration (RERpeak), gas exchange threshold (GET), time constants of oxygen on-/off-kinetics (τ), steady-state increase in oxygen uptake (ΔVO2), steady-state increase in heart rate (ΔHR), steady-state increase in expiratory volume (ΔVE)
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Change History | Complete list of historical versions of study NCT01679600 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise | ||||||||||||
Official Title ICMJE | Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial | ||||||||||||
Brief Summary | The propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular rehabilitation early after stroke. The investigators hypothesize that feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke. | ||||||||||||
Detailed Description | For detailed info: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial. Trials. 2013 Sep 22;14(1):304. | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
20 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date | April 2014 | ||||||||||||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Switzerland | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01679600 | ||||||||||||
Other Study ID Numbers ICMJE | CardioRobot | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Oliver Stoller, Bern University of Applied Sciences | ||||||||||||
Study Sponsor ICMJE | Bern University of Applied Sciences | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bern University of Applied Sciences | ||||||||||||
Verification Date | July 2015 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |