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临床试验/NCT06104982
NCT06104982已完成不适用

The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Modified Functional Reach Test (mFRT) (reaching of forward, right, left)

研究概览

简要总结

The primary aim of the current study was to investigate the effects of SiFES (superimposed functional electrical stimulation) on sitting balance in patients with complete Spinal Cord Injury (SCI) compared to exercise alone. Additionally, the study aims to investigate improvements in respiratory functions and changes in abdominal muscle thickness measured by ultrasonography (USG) following SiFES treatment.

The fundamental questions that investigators want to answer are as follows:

  • [question 1]: "Does abdominal SiFES therapy improve sitting balance in patients with complete SCI?"
  • [question 2]: "Does abdominal SiFES therapy improve respiratory functions in patients with complete SCI?"

详细描述

Many patients with SCI are ambulatory with a wheelchair. Therefore, providing good sitting balance in these patients is a key factor for performing activities of daily living (ADL) and achieving functional independence. Paralysis of abdominal muscles in patients with SCI disrupts body balance. In these patients, problems with trunk balance can lead to frequent falls and poor rehabilitation outcomes. Also, abdominal muscles assist in forceful expiration. Loss of innervation to abdominal and intercostal muscles reduces their ability to excrete secretions and cough effectively. As a result, respiratory tract complications, such as pneumonia, atelectasis, and respiratory failure can arise. It should be noted that in individuals with SCI, respiratory tract complications are the primary cause of morbidity and mortality. Newly used SiFES is a method in which the biofeedback-enabled FES device detects muscle contractions, and this electromyography (EMG) signal triggers the muscle stimulant mode of the device. In this method, more stimuli are conveyed to the brain through afferent nerves, allowing for motor learning to potentially occur by reviving the region represented in the cortex. In the current study, the investigators planned due to the anticipation that the synchronized stimulation of SiFES with function will be effective in patients with SCI injuries who currently have weak contraction abilities. The investigators considering the key role of abdominal muscles in trunk stability, believed that the integrated effect of SiFES is of great importance to patients. In the current randomized controlled and prospective study, the investigators included thirty-four participants with thoracic complete SCI. The investigators divided the participants into two equal groups: one group received SiFES applied to the abdominal muscles, while the control group received therapeutic exercise (TE) only. The investigators administered the interventions three times a week for four weeks. The investigators conducted muscle thickness measurements of bilateral rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA) muscles using ultrasonography for all participants before and after treatment. Additionally, the investigators applied the modified functional reach test (mFRT), trunk control test (TCT), and pulmonary function test (PFT) to assess the participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •being between 18-65 years old
  • •having a minimum of 3 months since the spinal cord injury
  • •having complete paraplegia according American Spinal Injury Association (ASIA) disorder scale A due to traumatic spinal cord injury
  • •being able to sit unsupported in a wheelchair

排除标准

  • •malignancy,
  • •epilepsy, heart failure,
  • •intracardiac defibrillator (ICD)
  • •an open wound in the application area

研究组 & 干预措施

SiFES group

Experimental

The investigators applied FES to the abdominal muscles of the SiFES group bilaterally, using 2 units of NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices. The investigators conducted electrical stimulation for a total of 10 minutes per session, with 5 minutes dedicated to bilateral rectus abdominis (RA) and 5 minutes to bilateral obliques externus (OE), obliques internus (OI), and transversus abdominis (TA) muscles three days a week, a period of four weeks. The investigators triggered the initial contraction of the abdominal muscles by instructing the patient to slightly flex their head before the application of electrical stimulation. During this process, the contraction was detected by the surface EMG present in the FES device, and the abdominal muscles were stimulated with electrical impulses.

干预措施: NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices (Device)

Control group (TE group)

Active Comparator

The investigators administered isometric strengthening to the TE groups, three days a week, with three sets per session, a period of four weeks.

干预措施: Isometric strengthening exercises (Other)

结局指标

主要结局

Modified Functional Reach Test (mFRT) (reaching of forward, right, left)

时间窗: Baseline - week 4

The mFRT, which is a validated and reliable tool for measuring sitting balance in patients with SCI was used in this study. Before the investigators conducted the test, the participant was positioned in an upright sitting posture in a wheelchair. The investigators took measurements in three directions: forward reach (using the dominant extremity), right reach, and left reach, both before and after the treatment, for both groups. During the modified functional reach test, the participants reached out as far as possible in the forward, right, and left directions. The investigators repeated the test three times, and there was a 5-minute interval between each repetition. The investigators recorded the best measurement out of the three trials in centimeters.

次要结局

  • The flow rate between 25% and 75% of FVC (PEF 25%-75%)(Baseline - week 4)
  • Trunk Control Test (TCT),(Baseline - week 4)
  • Peak expiratory flow rate (PEF)(Baseline - week 4)
  • Forced expiratory volume in one second (FEV1)(Baseline - week 4)
  • FEV1/FVC(Baseline - week 4)
  • Abdominal muscle thickness, the thicknesses of the right and left rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA)(Baseline - week 4)
  • Forced vital capacity (FVC)(Baseline - week 4)
  • Maximum voluntary ventilation (MVV)(Baseline - week 4)
  • Vital capacity (VC)(Baseline - week 4)
  • Inspiratory capacity (IC)(Baseline - week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Handan Elif Nur BAYRAKTAR

Specialist Medical Doctor

Ankara City Hospital Bilkent

研究点 (1)

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