NCT03528148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

April 21, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

Post strokeGaitElliptical cross bike.Postural controlBalance

Outcome Measures

Primary Outcomes (1)

  • 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

    3 weeks

Study Arms (2)

active cycling group

EXPERIMENTAL

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: cyclingBehavioral: Physical therapy

control group

ACTIVE COMPARATOR

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

Interventions

cyclingBEHAVIORAL

Active cycling

active cycling group

Conventional physical therapy

active cycling groupcontrol group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Chou Li-Wei, PhD

    China Medical University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomize control trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician,rehabilitation department

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 17, 2018

Study Start

August 1, 2018

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations