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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan2 sites
  • Chun-Yu Yeh

    Taichung

  • Chung Shan Medical University

    Taichung

Other trials in Taiwan

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.

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 groups in NCT01099878
Study groupRoleWhat they receive
Cycling Exercise with Functional Electrical StimulationActive comparatorCycling Exercise with Functional Electrical Stimulation
Receives: Device: Cycling Exercise with Functional Electrical Stimulation
Cycling ExercisePlacebo comparatorCycling 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.

  1. First posted8 Apr 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionApr 2009
  4. Study completionDec 2009

Resources

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)
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

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.

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