Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
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ClinicalTrials.gov Identifier: NCT01679600 |
Recruitment Status
:
Completed
First Posted
: September 6, 2012
Results First Posted
: August 5, 2015
Last Update Posted
: August 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Cardiovascular Diseases | Device: Feedback-controlled robotics-assisted treadmill exercise Device: Robotics-assisted treadmill exercise | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: FC-RATE
Feedback-controlled robotics-assisted treadmill exercise
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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)
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Active Comparator: RATE
Robotics-assisted treadmill exercise
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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)
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- Peak Oxygen Uptake (V'O2peak) [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Switzerland | |
Reha Rheinfelden | |
Rheinfelden, Aargau, Switzerland, 4310 |
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 |
Additional Information:
Publications of Results:
Other Publications:
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 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:
Stroke Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases |