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

Purpose

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.

Condition	Intervention
Stroke Cardiovascular Diseases	Device: Feedback-controlled robotics-assisted treadmill exercise Device: Robotics-assisted treadmill exercise


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Bern University of Applied Sciences:

Primary Outcome Measures:

Aerobic capacity [ Time Frame: Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	20
Study Start Date:	August 2012
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FC-RATE Feedback-controlled robotics-assisted treadmill exercise	Device: Feedback-controlled robotics-assisted treadmill exercise Human-in-the-loop feedback system to control individual's active work rate Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland)
Active Comparator: RATE Robotics-assisted treadmill exercise	Device: Robotics-assisted treadmill exercise Conventional robotics-assisted treadmill exercise Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland)

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679600

Locations


Switzerland
Reha Rheinfelden
Rheinfelden, Aargau, Switzerland, 4310

Sponsors and Collaborators

Bern University of Applied Sciences

Maastricht University

Reha Rheinfelden

Swiss Federal Institute of Technology

Investigators


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

More Information

Additional Information:

Institute for Rehabilitation and Performance Technology This link exits the ClinicalTrials.gov site

Reha Rheinfelden This link exits the ClinicalTrials.gov site

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.


Responsible Party:	Oliver Stoller, cand. PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier:	NCT01679600 History of Changes
Other Study ID Numbers:	CardioRobot
Study First Received:	August 29, 2012
Last Updated:	August 25, 2014
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Bern University of Applied Sciences:


Rehabilitation Robotics-assisted Treadmill Exercise Aerobic Capacity Exercise Testing

ClinicalTrials.gov processed this record on March 03, 2015