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 ]

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 ]

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 ]
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 ]
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 ]
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 ]
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 ]
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 ]

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 (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 Arms

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

Sex/Gender

Sexes Eligible for Study:

All

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

PRS Account

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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