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

July 30, 2015 updated by: Oliver Stoller, Bern University of Applied Sciences

Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Aargau
      • Rheinfelden, Aargau, Switzerland, 4310
        • Reha Rheinfelden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lokomat system (Hocoma AG, Volketswil, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Oxygen Uptake (V'O2peak)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bern University of Applied Sciences

Collaborators

Swiss Federal Institute of Technology
Maastricht University
Reha Rheinfelden

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CardioRobot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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