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

Not Applicable

Completed

• Conditions: Stroke; Cardiovascular Diseases
• Interventions: Device: Feedback-controlled robotics-assisted treadmill exercise; Device: Robotics-assisted treadmill exercise

• Registration Number: NCT01679600
• Lead Sponsor: Bern University of Applied Sciences

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-30
• Last Update Submitted: 2015-07-30
• Results First Posted: 2015-08-05
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FC-RATE	Feedback-controlled robotics-assisted treadmill exercise	Feedback-controlled robotics-assisted treadmill exercise
RATE	Robotics-assisted treadmill exercise	Robotics-assisted treadmill exercise

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Uptake (V'O2peak)	4 weeks

Trial Locations

Locations (1)

Reha Rheinfelden; 🇨🇭 Rheinfelden, Aargau, Switzerland