StrokeNCT01679600
Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
A study testing Robotics-assisted treadmill exercise in people with Stroke and Cardiovascular Diseases, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiovascular Diseases
- What is being tested?
- Robotics-assisted treadmill exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Cardiovascular Diseases
- Being tested
- Feedback-controlled robotics-assisted treadmill exercise, Robotics-assisted treadmill exercise
- Keywords
- Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing
- Medical subject headings
- Stroke, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback-controlled robotics-assisted treadmill exerciseDevice
Also called Lokomat system (Hocoma AG, Volketswil, Switzerland)
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.
Robotics-assisted treadmill exerciseDevice
Also called Lokomat system (Hocoma AG, Volketswil, Switzerland)
Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
| Study group | Role | What they receive |
|---|---|---|
| FC-RATE | Experimental | Feedback-controlled robotics-assisted treadmill exercise Receives: Device: Feedback-controlled robotics-assisted treadmill exercise |
| RATE | Active comparator | Robotics-assisted treadmill exercise Receives: Device: Robotics-assisted treadmill exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Uptake (V'O2peak)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Reha Rheinfelden, Swiss Federal Institute of Technology
- Responsible party
- Principal investigator, Oliver Stoller, Bern University of Applied Sciences
- Investigators
- Rob A. de Bie, Prof., Study director, Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, NetherlandsKenneth J. Hunt, Prof., Study director, Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, SwitzerlandEling D. de Bruin, PD Dr., Study director, Institute of Human Movement Sciences and Sport, ETH Zurich, SwitzerlandThierry Ettlin, Prof., Principal investigator, Reha Rheinfelden, Rheinfelden, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679600
- Sponsor's protocol ID
- CardioRobot
- Status last verified
- Jul 2015
- First submitted
- 29 Aug 2012
- Last updated
- 5 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22727172Stoller 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.
PubMed 23597319Stoller 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.
PubMed 23510976Stoller 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.
PubMed 24053609Stoller 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.
PubMed 26050073
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT01679600
- Acronym / sponsor ID
- CardioRobot
- Conditions
- Stroke, Cardiovascular Diseases
- Keywords
- Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- Maastricht University, Reha Rheinfelden, Swiss Federal Institute of Technology
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Posted 5 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FC-RATE | Experimental | Device: Feedback-controlled robotics-assisted treadmill exerciseFeedback-controlled robotics-assisted treadmill exercise |
| RATE | Active comparator | Device: Robotics-assisted treadmill exerciseRobotics-assisted treadmill exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback-controlled robotics-assisted treadmill exerciseAlso: Lokomat system (Hocoma AG, Volketswil, Switzerland)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. | Device | FC-RATE |
| Robotics-assisted treadmill exerciseAlso: Lokomat system (Hocoma AG, Volketswil, Switzerland)Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only. | Device | RATE |
Primary outcome
Peak Oxygen Uptake (V'O2peak)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22727172Stoller 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.
- Background: PubMed 23597319Stoller 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.
- Background: PubMed 23510976Stoller 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.
- Background: PubMed 24053609Stoller 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.
- Results publication: PubMed 26050073Stoller 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.
- Institute for Rehabilitation and Performance TechnologyLink provided by the sponsor.
- Reha RheinfeldenLink provided by the sponsor.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob A. de Bie, Prof. study director
Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands
Kenneth J. Hunt, Prof. study director
Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland
Eling D. de Bruin, PD Dr. study director
Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotics-assisted treadmill exercise in people with Stroke and Cardiovascular Diseases, run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Uptake (V'O2peak) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679600, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.