Cycling Exercise With Functional Electrical Stimulation Improves Postural Control in Stroke Patients

Postural Control Clinical Trial

Official title:

Institutional Review Board of Chung Shan Medical University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099878
• Other study ID #: CS07136
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 6, 2010
• Last updated: April 6, 2010
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 70 Years

Eligibility

Inclusion Criteria:

• (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;

Exclusion Criteria:

• (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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postural Control

Intervention

Device:
• Cycling Exercise with Functional Electrical Stimulation
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 exercise
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.

Locations

Country	Name	City	State
Taiwan	Chun-Yu Yeh	Taichung
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan,