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

Sponsor

Chung Shan Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02069691

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: virtual reality-cycling training system	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Institutional Review Board of Chung Shan Medical University Hospital

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: virtual reality-cycling training system	Device: virtual reality-cycling training system

Arm

Intervention/Treatment

Experimental: virtual reality-cycling training system

Device: virtual reality-cycling training system

Outcome Measures

Primary Outcome Measures

pedal force of affected leg [up to 24 weeks]

Secondary Outcome Measures

asymmetrical ratio index [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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