The Effects of Elliptical Cross Training Bike for Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Behavioral: cycling; Behavioral: Physical therapy

• Registration Number: NCT03528148
• Lead Sponsor: China Medical University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-21
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-05
• Study First Posted: 2018-05-17
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21
• Study Start: 2018-08-01
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active cycling group	cycling	effect of combine cycling and conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.
active cycling group	Physical therapy	effect of combine cycling and conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.
control group	Physical therapy	effect of combine conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.

Primary Outcome Measures

Name	Time	Method
Gait	3 weeks	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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan