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The Effects of Elliptical Cross Training Bike for Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528148
Recruitment Status : Unknown
Verified May 2018 by Li-Wei Chou, China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : May 17, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Li-Wei Chou, 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: cycling Behavioral: Physical therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomize control trials
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: China Medical University Hospital Asia University Hospital
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 13, 2019
Estimated Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active cycling group
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.
Behavioral: cycling
Active cycling

Behavioral: Physical therapy
Conventional physical therapy

Active Comparator: control group
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.
Behavioral: Physical therapy
Conventional physical therapy




Primary Outcome Measures :
  1. Gait [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528148


Contacts
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Contact: Chou Li-Wei, PhD +886-4-22052121 ext 2381 chouliwe@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 999079
Contact: Chou Li-Wei, PhD    +886-4-22052121 ext 2381    chouliwe@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: Chou Li-Wei, PhD China Medical University Hospital
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Responsible Party: Li-Wei Chou, Attending physician,rehabilitation department, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03528148    
Other Study ID Numbers: CMUH107-REC2-026
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Wei Chou, China Medical University Hospital:
Post stroke
Gait
Elliptical cross bike.
Postural control
Balance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases