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

This study is currently recruiting participants.
Verified January 2013 by Bern University of Applied Sciences
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: January 20, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Stroke
Cardiovascular Diseases
 Device: Feedback-controlled robotics-assisted treadmill exercise
Device: Robotics-assisted treadmill exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bern University of Applied Sciences:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FC-RATE
Feedback-controlled robotics-assisted treadmill exercise
 Device: Feedback-controlled robotics-assisted treadmill exercise
Human-in-the-loop feedback system to control individual's active work rate
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
Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679600

Contacts
Contact: Oliver Stoller, cand. PhD 0041618365385 oliver.stoller@bfh.ch

Locations
Switzerland
Reha Rheinfelden Recruiting
Rheinfelden, Aargau, Switzerland, 4310
Contact: Oliver Stoller, cand. PhD     0041618365385     oliver.stoller@bfh.ch    
Sponsors and Collaborators
Bern University of Applied Sciences
Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology
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
  More Information

Additional Information:
Institute for Rehabilitation and Performance Technology  This link exits the ClinicalTrials.gov site
Reha Rheinfelden  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Oliver Stoller, cand. PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01679600     History of Changes
Other Study ID Numbers: CardioRobot
Study First Received: August 29, 2012
Last Updated: January 20, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Bern University of Applied Sciences:
Rehabilitation
Robotics-assisted Treadmill Exercise
Aerobic Capacity
Exercise Testing

Additional relevant MeSH terms:
Cardiovascular Diseases
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013