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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: August 25, 2014
Last verified: August 2014

August 29, 2012
August 25, 2014
August 2012
April 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01679600 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Cardiovascular Diseases
  • 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)
  • Device: Robotics-assisted treadmill exercise
    Conventional robotics-assisted treadmill exercise
    Other Name: Lokomat system (Hocoma AG, Volketswil, Switzerland)
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01679600
CardioRobot
Yes
Oliver Stoller, Bern University of Applied Sciences
Bern University of Applied Sciences
  • Maastricht University
  • Reha Rheinfelden
  • Swiss Federal Institute of Technology
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
Bern University of Applied Sciences
August 2014

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