The Effect of Speed-based Training on Spasticity and Balance

NCT ID: NCT05256030

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-01

Brief Summary

While there are many studies examining the effect of different exercises on spasticity and balance activities in individuals with stroke, no study has been found on the effect of speed-based re-learning training on spasticity and balance activities. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.

Detailed Description

Stroke is one of the diseases with the highest mortality and disability rates worldwide. Spasticity is a motor disorder that affects more than 12 million people worldwide after stroke and is one of the most important causes of disability. Physiologically, spasticity affects the motor pathways of the brainstem and alters the excitability of motor neurons in the spinal cord, resulting in a reduction in the supraspinal-inhibitory-control mechanisms necessary for the regulation of the stretch reflex.

Spasticity is generally defined as "a motor disorder characterized by a speed-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex as a component of the upper motor neuron syndrome". The muscle that develops spasticity creates a resistance to the movement during different movements and activities and makes it difficult to perform the movement. The resistance felt is due not only to neural causes, but also to peripheral causes (biomechanical factors such as soft tissue or muscle properties). Spasticity shows different characters at different speeds. The velocity-dependent increase in muscle tone is an important feature of spasticity. The stretching speed has obvious effects on the catching angle. However, the velocity dependence of spasticity may be partially dependent on joint angle position.

Spasticity, which occurs due to a structural and physiological anomaly, creates a disordered contractile behavior characteristic in the structures of the muscles it affects. Therefore, spasticity should be considered not only as a rehabilitated phenomenon, but also as a disrupted behavior pattern that should be suppressed. In spastic cases, lesion of the motor cortex and corticospinal tract is accompanied by loss of supraspinal inhibition. During activities such as standing and walking, spasticity leads to the activation of a synergistic pattern. Depending on the increase in the extensor tone of the upper extremities, flexor lower extremities, balance and gait problems occur in various degrees in patients. Spasticity reduces functional capacity, increases metabolic energy expenditure and causes disruptions in daily work. Considering the number of people affected by spasticity and functional disability caused by the neural and motor sequelae of the disease, it is of great importance to seek new forms of evaluation and treatment for the rehabilitation of affected patients.

Improving walking safety and speed and preventing falls are the main goals of gait rehabilitation for stroke survivors. For these reasons, the patient should be approached from a holistic point of view rather than the classical point of view in stroke rehabilitation. Hemiplegic gait is not the result of isolated skeletal muscle dysfunction seen after orthopedic disorders. Therefore, spasticity and spastic activation time should be considered in the treatment. Walking is not only a displacement activity; It should be considered as a concept that includes the simultaneous coordination of all the muscles that need to be active, providing the highest efficiency and quality with the least energy expenditure.

The spastic threshold rate is defined as the minimum rate at which spastic response is observed during controlled open chain measurements. It is estimated that the spastic threshold rate decreases as the severity of stroke increases in stroke patients. However, the relationship between the onset of stretch-induced muscle activation and the resistance (catching) felt by clinicians in stroke survivors has not been fully investigated. Also, it is not clear whether the catch angle also depends on the joint angle position. Spasticity is clinically related to speed, joint position, angle of capture, etc. should be revealed quickly, rehabilitation practices should be made specific to the person and the activity. By raising the spastic rate threshold, the emergence of spasticity in the early phase should be prevented, even at higher velocities. In the management of spasticity, with a current point of view, classical rehabilitation practices should be avoided and motor learning strategies specific to the patient should be introduced. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.

Conditions

Stroke; Spasticity, Muscle; Balance; Distorted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control-Traditional Rehabilitation Group

This group will receive a 6-week neurorehabilitation program that includes stretching for spasticity inhibition, strengthening of the antagonist muscle, autogenic inhibition methods, as well as conscious-unconscious balance training and gait training, which are routinely applied in physical therapy and rehabilitation units. The treatment will be applied 5 days a week.

In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions

Group Type: EXPERIMENTAL

Speed-based relearning training

Intervention Type: OTHER

Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.

Study-Neurodevelopmental Therapy Group

Function-oriented Neurodevelopmental Therapy will be applied to the subjects included in the study and randomly assigned to the study group in different positions such as supine, prone, sitting, standing for 6 weeks, 5 sessions per week, and the goal will be to achieve the task at different speeds. Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.

Group Type: EXPERIMENTAL

Neurodevelopmental Therapy

Intervention Type: OTHER

Neurodevelopmental Therapy

Interventions

Speed-based relearning training

Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.

Intervention Type: OTHER

Neurodevelopmental Therapy

Neurodevelopmental Therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Post-stroke hemiparetic-hemiplegic clinical picture
• Getting 0-3 points according to the Modified Rankin Scale
• Brunnstorm lower extremity stage≥ 2
• Getting a score of 24 or higher on the Mini Mental test
• Being clinically stable
• Having a stroke for the first time
• Single hemisphere involvement

Exclusion Criteria

• Not having spasticity
• Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suleyman Demirel University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Duray

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mehmet Duray

Isparta, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Mehmet Duray

Role: CONTACT

mehmetduray@gmail.com

+902462113268

Other Identifiers

E-60116787-020-168618

Identifier Type: -

Identifier Source: org_study_id