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

This study has been completed.

Sponsor:

Collaborators:

Maastricht University

Reha Rheinfelden

Swiss Federal Institute of Technology

Information provided by (Responsible Party):

Oliver Stoller, Bern University of Applied Sciences

ClinicalTrials.gov Identifier:

NCT01679600

First received: August 29, 2012

Last updated: July 30, 2015

Last verified: July 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2012

Last Updated Date

July 30, 2015

Start Date ^ICMJE

August 2012

Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak Oxygen Uptake (V'O2peak) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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)

Change History

Complete list of historical versions of study NCT01679600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

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 ]
Locomotor functions (maximum voluntary isometric contraction, range of motion, spasticity) [ 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Stroke
Cardiovascular Diseases

Intervention ^ICMJE

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)
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)

Study Arm (s)

Experimental: FC-RATE
Feedback-controlled robotics-assisted treadmill exercise

Intervention: Device: Feedback-controlled robotics-assisted treadmill exercise
Active Comparator: RATE
Robotics-assisted treadmill exercise

Intervention: Device: Robotics-assisted treadmill exercise

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2014

Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01679600

Other Study ID Numbers ^ICMJE

CardioRobot

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Oliver Stoller, Bern University of Applied Sciences

Study Sponsor ^ICMJE

Bern University of Applied Sciences

Collaborators ^ICMJE

Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology

Investigators ^ICMJE

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

Information Provided By

Bern University of Applied Sciences

Verification Date

July 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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