The Effects of Elliptical Cross Training Bike for Stroke Patients

Stroke Clinical Trial

Official title:

China Medical University Hospital Asia University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528148
• Other study ID #: CMUH107-REC2-026
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 13, 2019

Study information

• Verified date: May 2018
• Source: China Medical University Hospital
• Contact: Chou Li-Wei, PhD
• Phone: +886-4-22052121
• Email: chouliwe[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of elliptical cross bike exercises combine conventional physical therapy on gait, postural control, balance, muscle tone, spasticity, quality of life, motor functioning, functional activity, and ADL in post stroke patients.

Description:

In a single-blind, randomized controlled intervention, patients were randomly assigned to an active cycling group (ACG, n=25) five times a week combine with conventional al physical therapy or a control group (CG, n=25) with conventional physical therapy 3 weeks of training in the center.

All outcome measures were administered at the beginning of the study, at the end of the 1st, 2nd, and 3rd week.

All participants will be divided two groups. One group will be experiment with conventional physical therapy as control group (CG), the other group will active cycling as active cycling group (ACG) with elliptical Cross Trainer & Exercise Bike after conventional physical therapy.

Baseline assessment of muscle tone by Myoton-3, Modified Ashworth Scale used as a simple measure of spasticity; Barthel Index scale for performance in activities of daily living; Berg Balance Scale to measure balance; the upper and lower limb subscale of the Fugl-Meyer assessment for motor function of extremities; and BTS G-WALK was used to measure gait parameters. The data will be collect before session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First-ever stroke (World Health Organization ,1978).

• Joint mobility ranges of lower extremity that would not preclude pedaling(Ambrosini, Ferrante et al. 2011).

• Unilateral hemiplegia.

• Able to carry out simple instructions.

• Able to sit independent at least 20 minutes and pedal an elliptical cross bike.

Exclusion Criteria:

• Neurologic disorders with impaired functionality existing pre-stroke.

• Patients could not follow instructions.

• Cardiovascular disease or other risk factor which precluded participation in aerobic exercise.

• Peripheral neuropathy that could potentially interfere with this study.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• cycling
Active cycling
• Physical therapy
Conventional physical therapy

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait	Subjects were asked to walk at a self-selected speed using walking aids if necessary with 10 m. BTS G-WALK was used to measure characterized of the hemiparetic gait such as speed, cadence and step length of the stroke patients	3 weeks