Cardiovascular Diseases, Stroke
Conditions
Keywords
Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing
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.
Interventions
DEVICEFeedback-controlled robotics-assisted treadmill exercise
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.
DEVICERobotics-assisted treadmill exercise
Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
Sponsors
Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology
Bern University of Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Oxygen Uptake (V'O2peak) | 4 weeks |
Countries
Switzerland
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| RATE Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | FC-RATE | RATE | Total |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 11 |
| Functional Ambulation Classification (0-5) | 1 units on a scale STANDARD_DEVIATION 0.8 | 0.9 units on a scale STANDARD_DEVIATION 1 | 1 units on a scale STANDARD_DEVIATION 0.8 |
| Hemiparetic side: right/left left | 2 participants | 5 participants | 7 participants |
| Hemiparetic side: right/left right | 5 participants | 2 participants | 7 participants |
| Region of Enrollment Switzerland | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
| Time poststroke | 52 days STANDARD_DEVIATION 42 | 45 days STANDARD_DEVIATION 30 | 52 days STANDARD_DEVIATION 31 |
| Type of stroke: ischemic/hemorrhagic hemorrhagic | 2 participants | 0 participants | 2 participants |
| Type of stroke: ischemic/hemorrhagic ischemic | 5 participants | 7 participants | 12 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Peak Oxygen Uptake (V'O2peak)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FC-RATE | Peak Oxygen Uptake (V'O2peak) | 1461 mL/min | Standard Deviation 683 |
| RATE | Peak Oxygen Uptake (V'O2peak) | 1494 mL/min | Standard Deviation 672 |
p-value: 0.53F1-LD-F1 model by Brunner and Langer