Cycling Exercise With Functional Electrical Stimulation Improves Postural Control in Stroke Patients
Institutional Review Board of Chung Shan Medical University Hospital
1 other identifier
interventional
20
1 country
2
Brief Summary
The aim of this study is to determine whether a short-term of FES assisted cycling in stroke patients can reduce the muscle tone of the affected leg immediately and the influence the postural control of the subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2009
2 active sites
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
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 8, 2010
CompletedApril 8, 2010
April 1, 2010
3 months
April 6, 2010
April 6, 2010
Conditions
Keywords
Study Arms (2)
Cycling Exercise with Functional Electrical Stimulation
ACTIVE COMPARATORCycling Exercise with Functional Electrical Stimulation
Cycling Exercise
PLACEBO COMPARATORCycling Exercise
Interventions
The subjects were randomly assigned to the cycling group (CG) performing cycling training without electrical stimulation or the FES-cycling group (FES-CG) performing the same training with the assistance of electrical stimulation. The duration of the training program was 20 minutes. The target cycling cadence was set at 45 rpm.
The subjects were randomly assigned to the cycling group (CG) performing cycling training without electrical stimulation or the FES-cycling group (FES-CG) performing the same training with the assistance of electrical stimulation. The duration of the training program was 20 minutes. The target cycling cadence was set at 45 rpm.
Eligibility Criteria
You may qualify if:
- (1)First-ever stroke with unilateral hemiplegia (Brunnstrom stage ≥3);
- (2)Hypertonia in the paretic leg, modified Ashworth scale (MAS) grade of ≥1;
- (3)Ability to understand and follow verbal commands;
You may not qualify if:
- (1)Severe perceptual, cognitive, or sensory deficits;
- (2)History of osteoarthritis, severe cardiopulmonary disease, or vascular disease in the lower limbs;
- (3)Fixed contracture in the paretic lower limb.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chun-Yu Yeh
Taichung, Taiwan
Chung Shan Medical University
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun -Yu Yeh, PT, PhD
Chung Shan Medical University
- STUDY CHAIR
Chun-Yu Yeh, PT;PhD
Chung Shan Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 8, 2010
Study Start
January 1, 2009
Primary Completion
April 1, 2009
Study Completion
December 1, 2009
Last Updated
April 8, 2010
Record last verified: 2010-04