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
  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:


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 ]

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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)

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679600

Locations
Switzerland
Reha Rheinfelden
Rheinfelden, Aargau, Switzerland, 4310
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:
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: August 25, 2014
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:
Stroke
Cerebral Infarction
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014