Postural ControlPhase 1/2NCT01099878
Cycling Exercise With Functional Electrical Stimulation Improves Postural Control in Stroke Patients
A Phase 1/2 study testing Cycling Exercise with Functional Electrical Stimulation and cycling exercise in people with Postural Control, run by Chung Shan Medical University at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 70 years
- Conditions the study is for
- Postural Control
- What is being tested?
- Cycling Exercise with Functional Electrical Stimulation and cycling exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
Who cannot join
- (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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Institutional Review Board of Chung Shan Medical University Hospital
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.
Read the detailed description
Patients with stroke frequently results in secondary complications of the neuromuscular system. For post-stroke patients, varying deficits in sensation, muscle strength, muscle tone and associated reaction in the paretic limbs often affect the activities of daily living. Cycling exercise is commonly suggested to improve cardiovascular fitness and functional mobility in patients with stroke. (Janssen, 2008; Holt, 2001; Potempa 1995) Cycling exercise requires less balance capacity and exercise intensity can be controlled. The kinematic patterns of cycling are very similar to that of walking that is one of the most important motor functions to recover in a stroke patient (Ferrante, 2008). Others studies have reported that repetitive passive movement of spastic muscle can increase range motion and reduce stiffness of hypertonic joints in stroke patients (Bressel, 2002; Yeh, 2007). Above studies (Bressel, 2002; Yeh, 2007) suggest leg cyclic movement may be a possible therapeutic modality to reduce hypertonia that is one of the factors disturbed the functional activities for stroke patients.
The application of functional electrical stimulation (FES) is usually used in physical therapy to assist the paretic limb to perform functional tasks (5-7). The previous studies reported the functional tasks of hemiplegic hands are improved after electrical stimulation treatment (Wu, 2006; Santos, 2006). FES has also been used to improve the walking ability of subjects with stroke (Bogataj, 1989; Yan, 2005; Salm, 2006). Clinical studies on central motor neuroplasticity also support the role of goal-oriented, repetitive, active movement in the therapy of paretic limbs to enhance motor recovery and relearning in stroke patients. (Ferrante, 2008) In the first half of the 1980s, FES was applied during cycling exercise on the paretic legs of people with spinal cord injury (SCI). The beneficial effects of cycling exercise via FES have evidenced increases in muscle strength and endurance, increases in bone density, suppression of spasticity, improvement of cardiopulmonary function, and many other physiological and psychological effects of benefit for SCI patients (Donaldson et al., 2000; Gfohler and Lugner, 2000; Gfohler et al., 2001). Recently, similar FES assisted cycling devices have also been used for stroke patients (Janssen, 2008; Ferrante, 2008). They reported that FES assisted training provided increased aerobic capacity and functional performance for them. However, in one study (Janssen, 2008) the functional performance was evaluated by clinical scales which do not reflect the changes on the affected limb influenced by the training exercise. It is worthwhile to realize the effects on the affected leg and the changes on postural control after the FES-cycling training.
A new FES-cycling device (Figure.1), modified from our previous prototype (Chen, 2004), was used in this study. This device combines FES with a cycling system equipped with ankle-foot orthoses. The FES stimulates the quadriceps and hamstring when the affected leg sweeps past a specific angle. The aims of this study were to determine whether a short-term of FES-cycling program in stroke patients can reduce the muscle tone of the affected leg immediately and influence the postural control of the subjects.
- Conditions
- Postural Control
- Being tested
- Cycling Exercise with Functional Electrical Stimulation, cycling exercise
- Keywords
- Cycling Exercise, Functional Electrical Stimulation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling Exercise with Functional Electrical StimulationDevice
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.
cycling exerciseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cycling Exercise with Functional Electrical Stimulation | Active comparator | Cycling Exercise with Functional Electrical Stimulation Receives: Device: Cycling Exercise with Functional Electrical Stimulation |
| Cycling Exercise | Placebo comparator | Cycling Exercise Receives: Device: cycling exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Chun -Yu Yeh, PT, PhD, Principal investigator, Chung Shan Medical UniversityChun-Yu Yeh, PT;PhD, Study chair, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099878
- Sponsor's protocol ID
- CS07136
- Status last verified
- Apr 2010
- First submitted
- 6 Apr 2010
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Review Board of Chung Shan Medical University Hospital
- ClinicalTrials.gov ID
- NCT01099878
- Acronym / sponsor ID
- CS07136
- Conditions
- Postural Control
- Keywords
- Cycling Exercise, Functional Electrical Stimulation, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with stroke frequently results in secondary complications of the neuromuscular system. For post-stroke patients, varying deficits in sensation, muscle strength, muscle tone and associated reaction in the paretic limbs often affect the activities of daily living. Cycling exercise is commonly suggested to improve cardiovascular fitness and functional mobility in patients with stroke. (Janssen, 2008; Holt, 2001; Potempa 1995) Cycling exercise requires less balance capacity and exercise intensity can be controlled. The kinematic patterns of cycling are very similar to that of walking that is one of the most important motor functions to recover in a stroke patient (Ferrante, 2008). Others studies have reported that repetitive passive movement of spastic muscle can increase range motion and reduce stiffness of hypertonic joints in stroke patients (Bressel, 2002; Yeh, 2007). Above studies (Bressel, 2002; Yeh, 2007) suggest leg cyclic movement may be a possible therapeutic modality to reduce hypertonia that is one of the factors disturbed the functional activities for stroke patients.
The application of functional electrical stimulation (FES) is usually used in physical therapy to assist the paretic limb to perform functional tasks (5-7). The previous studies reported the functional tasks of hemiplegic hands are improved after electrical stimulation treatment (Wu, 2006; Santos, 2006). FES has also been used to improve the walking ability of subjects with stroke (Bogataj, 1989; Yan, 2005; Salm, 2006). Clinical studies on central motor neuroplasticity also support the role of goal-oriented, repetitive, active movement in the therapy of paretic limbs to enhance motor recovery and relearning in stroke patients. (Ferrante, 2008) In the first half of the 1980s, FES was applied during cycling exercise on the paretic legs of people with spinal cord injury (SCI). The beneficial effects of cycling exercise via FES have evidenced increases in muscle strength and endurance, increases in bone density, suppression of spasticity, improvement of cardiopulmonary function, and many other physiological and psychological effects of benefit for SCI patients (Donaldson et al., 2000; Gfohler and Lugner, 2000; Gfohler et al., 2001). Recently, similar FES assisted cycling devices have also been used for stroke patients (Janssen, 2008; Ferrante, 2008). They reported that FES assisted training provided increased aerobic capacity and functional performance for them. However, in one study (Janssen, 2008) the functional performance was evaluated by clinical scales which do not reflect the changes on the affected limb influenced by the training exercise. It is worthwhile to realize the effects on the affected leg and the changes on postural control after the FES-cycling training.
A new FES-cycling device (Figure.1), modified from our previous prototype (Chen, 2004), was used in this study. This device combines FES with a cycling system equipped with ankle-foot orthoses. The FES stimulates the quadriceps and hamstring when the affected leg sweeps past a specific angle. The aims of this study were to determine whether a short-term of FES-cycling program in stroke patients can reduce the muscle tone of the affected leg immediately and influence the postural control of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling Exercise with Functional Electrical Stimulation | Active comparator | Device: Cycling Exercise with Functional Electrical StimulationCycling Exercise with Functional Electrical Stimulation |
| Cycling Exercise | Placebo comparator | Device: cycling exerciseCycling Exercise |
Who may qualify
- Ages
- 29 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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;
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling Exercise with Functional Electrical StimulationThe 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. | Device | Cycling Exercise with Functional Electrical Stimulation |
| cycling exerciseThe 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. | Device | Cycling Exercise |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun -Yu Yeh, PT, PhD principal investigator
Chung Shan Medical University
Chun-Yu Yeh, PT;PhD study chair
Chung Shan Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cycling Exercise with Functional Electrical Stimulation and cycling exercise in people with Postural Control, run by Chung Shan Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2010.