Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679600
Recruitment Status : Completed
First Posted : September 6, 2012
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Collaborators:
Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Oliver Stoller, Bern University of Applied Sciences

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study 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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679600


Locations
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Oliver Stoller, cand. PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01679600    
Other Study ID Numbers: CardioRobot
First Posted: September 6, 2012    Key Record Dates
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:
Layout table for MeSH terms
Stroke
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases