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 (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: Cardiac Rehabilitation Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

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

Primary Outcome Measures:

Peak Oxygen Uptake (V'O2peak) [ Time Frame: 4 weeks ]


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 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)
Active Comparator: RATE Robotics-assisted treadmill exercise	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)

Arms

Assigned Interventions

Experimental: FC-RATE

Feedback-controlled robotics-assisted treadmill exercise

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)

Active Comparator: RATE

Robotics-assisted treadmill exercise

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)

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 (Adult, Senior)
Sexes Eligible for Study:	All
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, 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.

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
Results First Received:	July 3, 2015
Last Updated:	July 30, 2015

Keywords provided by Oliver Stoller, Bern University of Applied Sciences:


Rehabilitation Robotics-assisted Treadmill Exercise Aerobic Capacity Exercise Testing

Additional relevant MeSH terms:


Stroke Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 19, 2017