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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679600
• Other study ID #: CardioRobot
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: July 30, 2015
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Bern University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Stroke

Intervention

Device:
• Feedback-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.
• Robotics-assisted treadmill exercise
Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden	Aargau

Sponsors (4)

Lead Sponsor	Collaborator
Bern University of Applied Sciences	Maastricht University, Reha Rheinfelden, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. Review. — View 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. — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Uptake (V'O2peak)		4 weeks	No

External Links

•   Institute for Rehabilitation and Performance Technology
•   Reha Rheinfelden