Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial

Conditions
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Stroke, Cardiovascular Diseases

Intervention / Treatment
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* Device: Feedback-controlled robotics-assisted treadmill exercise
* Device: Robotics-assisted treadmill exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FC-RATE<br>Feedback-controlled robotics-assisted treadmill exercise | Device: Feedback-controlled robotics-assisted treadmill exercise<br>* 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.<br>* Other names: Lokomat system (Hocoma AG, Volketswil, Switzerland);|
| Active Comparator: RATE<br>Robotics-assisted treadmill exercise | Device: Robotics-assisted treadmill exercise<br>* Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.<br>* Other names: Lokomat system (Hocoma AG, Volketswil, Switzerland);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Uptake (V'O2peak) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Robotics-assisted Treadmill Exercise, Aerobic Capacity, Exercise Testing