The Effects of Elliptical Cross Training Bike for Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cycling
Physical therapy
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Post stroke, Gait, Elliptical cross bike., Postural control, Balance
Eligibility Criteria
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.
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
active cycling group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03528148
First Posted
April 21, 2018
Last Updated
May 18, 2018
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03528148
Brief Title
The Effects of Elliptical Cross Training Bike for Stroke Patients
Official Title
China Medical University Hospital Asia University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
March 13, 2019 (Anticipated)
Study Completion Date
March 13, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Post stroke, Gait, Elliptical cross bike., Postural control, Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomize control trials
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active cycling group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cycling
Intervention Description
Active cycling
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Intervention Description
Conventional physical therapy
Primary Outcome Measure Information:
Title
Gait
Description
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
Time Frame
3 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Elliptical Cross Training Bike for Stroke Patients
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