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Completed

NCT Number: NCT01679600

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feedback-controlled robotics-assisted treadmill exercise

Device

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.

Other names: Lokomat system (Hocoma AG, Volketswil, Switzerland)

Robotics-assisted treadmill exercise

Device

Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.

Other names: Lokomat system (Hocoma AG, Volketswil, Switzerland)

Primary outcomes

  1. Peak Oxygen Uptake (V'O2peak)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Collaborators

  • Maastricht University
  • Reha Rheinfelden
  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2012
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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