The Effects of Elliptical Cross Training Bike for Stroke Patients

NCT ID: NCT03528148

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-13

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomize control trials
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

cycling

Intervention Type BEHAVIORAL

Active cycling

Physical therapy

Intervention Type BEHAVIORAL

Conventional physical therapy

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.

Group Type ACTIVE_COMPARATOR

Physical therapy

Intervention Type BEHAVIORAL

Conventional physical therapy

Interventions

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cycling

Active cycling

Intervention Type BEHAVIORAL

Physical therapy

Conventional physical therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li-Wei Chou

Attending physician,rehabilitation department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chou Li-Wei, PhD

Role: STUDY_CHAIR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chou Li-Wei, PhD

Role: CONTACT

+886-4-22052121 ext. 2381

Facility Contacts

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Chou Li-Wei, PhD

Role: primary

+886-4-22052121 ext. 2381

Other Identifiers

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CMUH107-REC2-026

Identifier Type: -

Identifier Source: org_study_id

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