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

Stroke Clinical Trial

Official title:

Institutional Review Board of Chung Shan Medical University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069691
• Other study ID #: CS11034
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 20, 2014
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2012
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• virtual reality-cycling training system

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pedal force of affected leg		up to 24 weeks	Yes
Secondary	asymmetrical ratio index		up to 24 weeks	Yes

External Links

•   CSMUH IRB