Clinical trial NCT01679600: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cardiovascular Diseases
Keywords: Rehabilitation
Robotics-assisted Treadmill Exercise
Aerobic Capacity
Exercise Testing
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Reha Rheinfelden
name: Swiss Federal Institute of Technology
First posted: 2012-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak Oxygen Uptake (V'O2peak)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
affiliation: Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands
name: Rob A. de Bie, Prof.
role: STUDY_DIRECTOR
affiliation: Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland
name: Kenneth J. Hunt, Prof.
role: STUDY_DIRECTOR
affiliation: Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland
name: Eling D. de Bruin, PD Dr.
role: STUDY_DIRECTOR
affiliation: Reha Rheinfelden, Rheinfelden, Switzerland
name: Thierry Ettlin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.