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The Effects of Elliptical Cross Training Bike for Stroke Patients

C

China Medical University

Status

Unknown

Conditions

Stroke

Treatments

Behavioral: Physical therapy
Behavioral: cycling

Study type

Interventional

Funder types

Other

Identifiers

NCT03528148
CMUH107-REC2-026

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

active cycling group
Experimental group
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.
Treatment:
Behavioral: Physical therapy
Behavioral: cycling
control group
Active Comparator group
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.
Treatment:
Behavioral: Physical therapy

Trial contacts and locations

1

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Central trial contact

Chou Li-Wei, PhD

Data sourced from clinicaltrials.gov

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