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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Cardiovascular Diseases	Device: Feedback-controlled robotics-assisted treadmill exercise; Device: Robotics-assisted treadmill exercise	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
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
Study Start Date :	August 2012
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Institute for Rehabilitation and Performance Technology 

Reha Rheinfelden 

Publications of Results:

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.

Other 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
First Posted:	September 6, 2012
Results First Posted:	August 5, 2015
Last Update Posted:	August 5, 2015
Last Verified:	July 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