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

NCT ID: NCT02069691

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

virtual reality-cycling training system

Group Type: EXPERIMENTAL

virtual reality-cycling training system

Intervention Type: DEVICE

Interventions

virtual reality-cycling training system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chun-Yu Yeh

pofessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chung Shan Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Related Links

http://www.csh.org.tw/IRB/Index.htm

CSMUH IRB

Other Identifiers

CS11034

Identifier Type: -

Identifier Source: org_study_id