Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Maastricht University | OTHER |
| Reha Rheinfelden | OTHER |
| Swiss Federal Institute of Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FC-RATE | Experimental | Feedback-controlled robotics-assisted treadmill exercise |
|
| RATE | Active Comparator | Robotics-assisted treadmill exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback-controlled robotics-assisted treadmill exercise | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen Uptake (V'O2peak) | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Thierry Ettlin, Prof. | Reha Rheinfelden, Rheinfelden, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reha Rheinfelden | Rheinfelden | Canton of Aargau | 4310 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22727172 | Background | 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. | |
| 23597319 | Background | 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. |
| Label | URL |
|---|---|
| Institute for Rehabilitation and Performance Technology | View source |
Not provided
6 subjects dropped out before assiggnment (abnormal gait pattern due to uncontrollable spasticity, tibia skin lesion due to inadequate padding during familiarization, lack of motivation to produce maximal work rate values, severe groin pain caused by the body weight support harness, suspected cerebrospinal fluid leak, acute respiratory infection)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FC-RATE | Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate |
| FG001 | RATE |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Robotics-assisted treadmill exercise | Device | Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only. |
|
|
| 23510976 | Background | 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. |
| 24053609 | Background | 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. |
| 26050073 | Result | 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. |
| Reha Rheinfelden | View source |
Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FC-RATE | Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate |
| BG001 | RATE | Robotics-assisted treadmill exercise Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Type of stroke: ischemic/hemorrhagic | Number | participants |
| ||||||||||||||||
| Hemiparetic side: right/left | Number | participants |
| ||||||||||||||||
| Functional Ambulation Classification (0-5) | Patients will be rated on the following 6 categories: 0: Patient cannot walk, or needs help from 2 or more persons. 1: Patients needs firm continuous support from 1 person who helps carrying weight and with balance. 2: Patient needs continuous or intermittent support of one person to help with balance and coordination. 3: Patient requires verbal supervision or stand-by help from one person without physical contact. 4: Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces. 5: Patient can walk independently anywhere. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Time poststroke | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Oxygen Uptake (V'O2peak) | Posted | Mean | Standard Deviation | mL/min | 4 weeks |
|
|
|
|
10/01/2012-03/31/2014
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FC-RATE | Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate | 0 | 7 | 0 | 7 | ||
| EG001 | RATE | Robotics-assisted treadmill exercise Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oliver Stoller | Bern University of Applied Sciences | +41344264195 | oliver.stoller@bfh.ch |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Male |
|
| hemorrhagic |
|
| left |
|