Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
Primary Purpose
Stroke, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Feedback-controlled robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing
Eligibility 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
Sites / Locations
- Reha Rheinfelden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FC-RATE
RATE
Arm Description
Feedback-controlled robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise
Outcomes
Primary Outcome Measures
Peak Oxygen Uptake (V'O2peak)
Secondary Outcome Measures
Full Information
NCT ID
NCT01679600
First Posted
August 29, 2012
Last Updated
July 30, 2015
Sponsor
Bern University of Applied Sciences
Collaborators
Maastricht University, Reha Rheinfelden, Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01679600
Brief Title
Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
Official Title
Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bern University of Applied Sciences
Collaborators
Maastricht University, Reha Rheinfelden, Swiss Federal Institute of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Diseases
Keywords
Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FC-RATE
Arm Type
Experimental
Arm Description
Feedback-controlled robotics-assisted treadmill exercise
Arm Title
RATE
Arm Type
Active Comparator
Arm Description
Robotics-assisted treadmill exercise
Intervention Type
Device
Intervention Name(s)
Feedback-controlled robotics-assisted treadmill exercise
Other Intervention Name(s)
Lokomat system (Hocoma AG, Volketswil, Switzerland)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Robotics-assisted treadmill exercise
Other Intervention Name(s)
Lokomat system (Hocoma AG, Volketswil, Switzerland)
Intervention Description
Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
Primary Outcome Measure Information:
Title
Peak Oxygen Uptake (V'O2peak)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob A. de Bie, Prof.
Organizational Affiliation
Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth J. Hunt, Prof.
Organizational Affiliation
Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eling D. de Bruin, PD Dr.
Organizational Affiliation
Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thierry Ettlin, Prof.
Organizational Affiliation
Reha Rheinfelden, Rheinfelden, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
4310
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22727172
Citation
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.
Results Reference
background
PubMed Identifier
23597319
Citation
Stoller 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.
Results Reference
background
PubMed Identifier
23510976
Citation
Stoller 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.
Results Reference
background
PubMed Identifier
24053609
Citation
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 randomised controlled pilot trial. Trials. 2013 Sep 22;14:304. doi: 10.1186/1745-6215-14-304.
Results Reference
background
PubMed Identifier
26050073
Citation
Stoller 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.
Results Reference
result
Links:
URL
http://irpt.ti.bfh.ch
Description
Institute for Rehabilitation and Performance Technology
URL
http://www.reha-rheinfelden.ch/
Description
Reha Rheinfelden
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Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise
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