Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
研究概览
简要总结
Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.
详细描述
Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.
Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
- •Cortical or subcortical stroke
- •Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale)
- •Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
- •Surface NMES of finger and thumb extensors produces functional hand opening without pain
- •Full volitional opening of the contralateral hand of the unimpaired side.
- •Able to follow 3 stage commands
- •Able to remember at least 2 of 3 items after 30 minutes
- •Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
- •Caregiver available and willing to help assist with the device and home regimen and ensure compliance
- •Skin intact on hemiparetic arm
- •Medically stable
排除标准
- •Insensate forearm and/or hand
- •Edema of the affected forearm and/or hand
- •History of potentially fatal cardiac arrhythmias.
- •Cardiac pacemakers or any other implanted electronic systems
- •Pregnant women
- •Uncontrolled seizure disorder
- •Severely impaired cognition or comprehension
- •Uncompensated hemineglect
- •Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
- •Ipsilateral lower motor neuron lesion
- •Parkinson's Disease
- •Spinal cord injury
- •Traumatic brain injury
- •Multiple sclerosis
- •Lack of functional passive range of motion of the wrist or fingers of affected side
- •Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
- •Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months
研究组 & 干预措施
CCFES
CCFES - Contralaterally Controlled Functional Electrical Stimulation
- Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
- A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
- Therapy sessions are done with the subject being assisted by the CCFES system.
干预措施: Neuromuscular electrical stimulator (Device)
cNMES
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
- Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
- Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
- Therapy sessions are done without the stimulation system
干预措施: Neuromuscular electrical stimulator (Device)
结局指标
主要结局
Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
时间窗: 3 months post-treatment.
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.
次要结局
- Finger Tracking Error(3 months post-treatment.)
- Box and Blocks Score(3 months post-treatment.)
- Arm Motor Abilities Test(3 months post-treatment.)
- Fugl-Meyer Assessment (Upper Extremity)(3 months post-treatment.)
研究者
Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
MetroHealth Medical Center