Skip to main content
OpenTrials
Completed

NCT Number: NCT02069691

The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients

Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and balancing ability. Many studies point out that cycling is an effective means for lower limb rehabilitation. However, during training, the unaffected limb may compensate for the affected one resulting in suboptimal rehabilitation. To address this issue, the investigators developed the virtual reality-cycling training system (VRCTS) which can acquire force and speed signals in real-time through a cycling module. The system then analyzes the acquired data and uses a 3D VR rehabilitation program to help patients to train their affected side. The aim of the study was to develop the VRCTS, verify its function and test system function on both normal subjects and stroke patients.

Methods: In this system, the investigators designed a cycling device that is embedded with load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph User Interface Control and Data Recode System (Cycling CR System) was applied for signal analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation program that can guide and train the users through visual feedback. Each user performed a pre-test to examine determine condition, left-right balance and other parameters, which allows the system to be customized.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • single stroke with unilateral hemiplegia (Brunnstrom stage III);
  • hypertonia in the affected leg, modified Ashworth scale (MAS) grade ≦ 2;
  • no significant perceptual, cognitive, or sensory deficits;
  • no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs
  • lack of a fixed contracture in the affected lower limb

Treatment and study plan

virtual reality-cycling training system

Device

Primary outcomes

  1. pedal force of affected leg

    Time frame: up to 24 weeks

Secondary outcomes

  1. asymmetrical ratio index

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Institutional Review Board of Chung Shan Medical University Hospital

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 24, 2014
Registry last updated
Feb 24, 2014

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.

Published trials that share one or more normalized conditions with this study.