Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
September 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
August 5, 2015
CompletedAugust 5, 2015
July 1, 2015
1.7 years
August 29, 2012
July 3, 2015
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Oxygen Uptake (V'O2peak)
4 weeks
Study Arms (2)
FC-RATE
EXPERIMENTALFeedback-controlled robotics-assisted treadmill exercise
RATE
ACTIVE COMPARATORRobotics-assisted treadmill exercise
Interventions
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.
Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bern University of Applied Scienceslead
- Maastricht Universitycollaborator
- Reha Rheinfeldencollaborator
- Swiss Federal Institute of Technologycollaborator
Study Sites (1)
Reha Rheinfelden
Rheinfelden, Canton of Aargau, 4310, Switzerland
Related Publications (5)
Stoller O, de Bruin ED, Knols RH, Hunt KJ. Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis. BMC Neurol. 2012 Jun 22;12:45. doi: 10.1186/1471-2377-12-45.
PMID: 22727172BACKGROUNDStoller O, Schindelholz M, Bichsel L, Schuster C, de Bie RA, de Bruin ED, Hunt KJ. Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. Disabil Rehabil Assist Technol. 2014 Jul;9(4):271-8. doi: 10.3109/17483107.2013.785038. Epub 2013 Apr 18.
PMID: 23597319BACKGROUNDStoller O, de Bruin ED, Schindelholz M, Schuster C, de Bie RA, Hunt KJ. Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. Technol Health Care. 2013;21(2):157-66. doi: 10.3233/THC-130730.
PMID: 23510976BACKGROUNDStoller 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 randomised controlled pilot trial. Trials. 2013 Sep 22;14:304. doi: 10.1186/1745-6215-14-304.
PMID: 24053609BACKGROUNDStoller O, de Bruin ED, Schindelholz M, Schuster-Amft C, de Bie RA, Hunt KJ. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial. J Neurol Phys Ther. 2015 Jul;39(3):156-65. doi: 10.1097/NPT.0000000000000095.
PMID: 26050073RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Oliver Stoller
- Organization
- Bern University of Applied Sciences
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- cand. PhD
Study Record Dates
First Submitted
August 29, 2012
First Posted
September 6, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 5, 2015
Results First Posted
August 5, 2015
Record last verified: 2015-07