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临床试验/NCT04876703
NCT04876703Unknown不适用

Effectiveness of Multichannel Functional Electrical Stimulation on Upper Extremity Function During Stroke Rehabilitation

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Change in The Box and Block Test (BBT)

研究概览

简要总结

The purpose of this pilot study is to determine whether two weeks of multi-channel FES along with task-specific training will improve UE function when compared to traditional rehabilitation or usual care. The secondary purpose of this study is to find whether two weeks of multi-channel FES along with task-specific training will improve shoulder range of motion, grip strength, and patient reported function when compared to traditional rehabilitation or usual care in patients with unilateral stroke resulting in hemiplegia.The following null hypotheses are established for this study:

  1. There will be no difference in UE function when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation.
  2. There will be no difference in shoulder range of motion and grip strength when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation.
  3. There will be no difference in self-reported upper extremity function when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation.The research design for this experimental study will be a randomized controlled trial. The manipulated independent variable in this study will be 1) FES using Xcite with traditional therapy and 2) traditional therapy. The dependent variables in this study are the following: Upper extremity function measured by The Action Research Arm Test, The Box and Block Test, and The Nine-Hole Peg Test; Grip strength measured using a dynamometer; Range of motion at the shoulder measured using a standard goniometer; and Participants' perception of improvement in function measured by a modified Patient-Specific Functional Scale.

详细描述

I. BACKGROUND AND SIGNIFICANCE Stroke is the third leading cause of death and is a major reason for disability among survivors (Mayo 2009). 55-75% of patients with stroke have deficiency in upper extremity (UE) function contributing to the disability (Alon, 2007). Complete recovery of UE function is only reported in 11.6% of stroke survivors 6 months following ischemic middle cerebral artery stroke (Kwakkel, 2003). Neuro rehabilitation has shifted focus to task-specific, repetitive training as we understood the concept of neuroplasticity (Kleim, 2008 ). Functional electrical stimulation (FES) has been identified as a treatment modality to enhance upper extremity function in patients during early stroke rehabilitation (Alon, 2007). FES along with task-specific training has demonstrated superior performance in hand function (Yang et al 2019) Though studies have reported improvement in UE function, the duration of treatment and timing post stroke also varies tremendously. Since the majority of the improvement in upper extremity function occurs in 11 weeks since onset (Nakayama, 1994), it is important to consider the effect of FES during that time in enhancing UE function. FES can be an expensive modality to use for patients on their own and therefore the length of stay at inpatient rehabilitation post stroke also is an important factor to consider. The average reported length of stay during inpatient rehab for patients with stroke varies from 9 to 22 days (Camicia, 2015). So it is important to assess the effectiveness of FES during the patient's inpatient stay for clinicians to choose the most appropriate intervention during the limited inpatient rehabilitation time. Most of the reported studies have used FES distally (Alon, 2007; Gharib, 2015) to improve hand function however it is also important to consider the role of proximal stability to improve UE function for tasks such as reaching. Though FES of the proximal muscles has been shown to be a superior intervention in reducing shoulder subluxation, its effect on improving motor function has been inconclusive (Vafadar et al 2015).

Traditionally, FES machines are a two-channel unit used to stimulate one muscle group at a time. The Xcite system is a battery-powered stimulator with up to 12 channels of cyclical stimulation, allowing for both proximal and distal muscle group stimulation. It is a task-specific modality to enhance mass practice during neurological re-education. Each activity has the correctly sequenced stimulation pattern to perform the prescribed activity. There has been limited research regarding this type of FES in patients with stroke during early stroke rehabilitation.

II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES The purpose of this pilot study is to determine whether two weeks of multi-channel FES along with task-specific training will improve UE function when compared to traditional rehabilitation or usual care. The secondary purpose of this study is to find whether two weeks of multi-channel FES along with task-specific training will improve shoulder range of motion, grip strength, and patient reported function when compared to traditional rehabilitation or usual care in patients with unilateral stroke resulting in hemiplegia.

Null Hypotheses:

The following null hypotheses are established for this study:

研究设计

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

入排标准

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

入选标准

  • •first-time unilateral stroke survivors with less than 3 months since onset with upper extremity hemiplegia/hemiparesis over the age of 18

排除标准

  • •Participants who have comorbidities impacting motor function (Parkinson's, congenital disorders) or contraindications for NMES (seizure disorders, uncontrolled cardiac conditions, cancer, pacemaker, significant sensory deficits, contractures, pregnancy, unhealed fractures, or a cerebellar stroke), and who are unable to follow two-step commands

研究组 & 干预措施

Excite group (Group A)

Experimental

The experimental group (Group A) will receive standard motor retraining of the affected upper extremity in addition to functional electrical stimulation provided by means of Xcite system 4 days per week for 30 minutes for two weeks.

干预措施: Multichannel Functional electrical stimulation (Device)

Standard motor training group (Group B)

Active Comparator

The control group (Group B) will receive standard motor retraining of the upper extremity.

干预措施: Standard motor training (Other)

结局指标

主要结局

Change in The Box and Block Test (BBT)

时间窗: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.

The assessment measures number of blocks a patient can grasp and transfer over a partition in one minute. A score for BBT is calculated by counting the number of blocks that were transferred in one-minute trial.

Change in Action Research Arm Test (ARAT)

时间窗: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.

The Action Research Arm Test is a 19-item measure with 4 sub-categories (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning. The ARAT is scored on a 4-point original Scale (3-Performs test normally, 2- Completes test, but takes abnormally long or has great difficulty, 1- Performs test partially, 0- Can perform no part of test).

Change in The Nine-Hole Peg Test (NHPT)

时间窗: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.

The test includes use of a stop watch to calculate the amount of time needed to place and remove 9 pegs in holes on a pegboard. A score is calculated for the NHPT by the time taken to complete the activity (in seconds).

次要结局

  • Change in Upper extremity range of motion(Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.)
  • Change in modified Patient-Specific Functional Scale(Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.)
  • Change in Grip strength(Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention.)

研究者

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

Caitlin Boyd

Occupational Therapist

Baylor Research Institute

研究点 (1)

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