Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

Tracking Information
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; (submitted: July 30, 2015)	Peak Oxygen Uptake (V'O2peak) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures ICMJE; (submitted: September 3, 2012)	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)
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; (submitted: September 3, 2012)	10 Meter Walk Test (gait speed) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]; 6 Minute Walk Test (walking endurance) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]; Standing function (balance) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]; Locomotor functions (maximum voluntary isometric contraction, range of motion, spasticity) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]; Stroke Impact Scale (stroke recovery) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]; Feasibility (criteria for success) [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ]
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
Condition ICMJE	Stroke; Cardiovascular Diseases
Intervention ICMJE	Device: Feedback-controlled robotics-assisted treadmill exercise Progressive cardiovascular exercise using feedback-controlled robotics-assisted treadmill exercise. The first training session is defined to start at 40% of peak work rate (determined from a previous exercise test) to approach 40% of heart rate reserve (Borg scale approximately 11-14). The intensity will then be adjusted on the basis of continuous heart rate data and rating of perceived exertion indications by modulating the target work rate in 5% increments for every subsequent session to reach the target intensity. The target heart rate is set at 40% to 70% of heart rate reserve. Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland); Device: Robotics-assisted treadmill exercise Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only. Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland)
Study Arms	Experimental: FC-RATE Feedback-controlled robotics-assisted treadmill exercise Intervention: Device: Feedback-controlled robotics-assisted treadmill exercise; Active Comparator: RATE Robotics-assisted treadmill exercise Intervention: Device: Robotics-assisted treadmill exercise
Publications *	Stoller O, de Bruin ED, Knols RH, Hunt KJ. Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis. BMC Neurol. 2012 Jun 22;12:45. doi: 10.1186/1471-2377-12-45. Review.; Stoller O, Schindelholz M, Bichsel L, Schuster C, de Bie RA, de Bruin ED, Hunt KJ. Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. Disabil Rehabil Assist Technol. 2014 Jul;9(4):271-8. doi: 10.3109/17483107.2013.785038. Epub 2013 Apr 18.; Stoller O, de Bruin ED, Schindelholz M, Schuster C, de Bie RA, Hunt KJ. Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. Technol Health Care. 2013;21(2):157-66. doi: 10.3233/THC-130730.; 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 randomised controlled pilot trial. Trials. 2013 Sep 22;14:304. doi: 10.1186/1745-6215-14-304.; Stoller O, de Bruin ED, Schindelholz M, Schuster-Amft C, de Bie RA, Hunt KJ. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial. J Neurol Phys Ther. 2015 Jul;39(3):156-65. doi: 10.1097/NPT.0000000000000095.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 3, 2012)	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: Clinical diagnosis of an initial supratentorial stroke; ≤20 weeks post stroke at intervention onset; Age ≥18 years; Functional Ambulation Category (FAC) ≤3; Ability to understand the procedures and provide informed consent Exclusion Criteria: Contraindications for exercise testing outlined by American College of Sports Medicine (ACSM); Contraindications for RATE according to the manufacturer; Concurrent neurological disease; Concurrent pulmonary disease; History of dementia
Sex/Gender	Sexes Eligible for Study: All
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	Maastricht University; Reha Rheinfelden; Swiss Federal Institute of Technology
Investigators ICMJE	Study Director: Rob A. de Bie, Prof. Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands Study Director: Kenneth J. Hunt, Prof. Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland Study Director: Eling D. de Bruin, PD Dr. Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland Principal Investigator: Thierry Ettlin, Prof. Reha Rheinfelden, Rheinfelden, Switzerland
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