Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment
研究概览
简要总结
After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.
详细描述
A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
- •unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale
- •score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment
- •adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
- •able to follow 3-stage commands
- •able to recall at least 2 of a list of 3 items after 30 minutes
- •skin intact on the hemiparetic arm
- •surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity)
- •able to hear and respond to cues from stimulator
- •not receiving occupational therapy (no concomitant OT)
- •full voluntary opening/closing of the contralateral (less affected) hand
- •demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them
排除标准
- •co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
- •uncontrolled seizure disorder
- •brainstem stroke
- •uncompensated hemineglect
- •severe shoulder or hand pain
- •insensate forearm or hand
- •history of potentially fatal cardiac arrhythmias with hemodynamic instability
- •implanted electronic systems (e.g. pacemaker)
- •botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
- •pregnant women due to unknown risks of surface NMES during pregnancy
- •lack of functional passive range of motion of the wrist or fingers of affected side
- •diagnosis (apart from stroke) that substantially affects paretic arm and hand function
- •deficits in communication that interfere with reasonable study participation
- •lacking sufficient visual acuity to see the stimulator's display
- •concurrent enrollment in another investigational study
研究组 & 干预措施
CCFES
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
干预措施: Electrical Stimulator (Device)
CCFES
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
干预措施: Occupational Therapy (Behavioral)
cNMES
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
干预措施: Electrical Stimulator (Device)
cNMES
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
干预措施: Occupational Therapy (Behavioral)
Task Oriented Therapy
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
干预措施: Occupational Therapy (Behavioral)
结局指标
主要结局
Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment
时间窗: Baseline to 6 months post-treatment
The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
次要结局
- Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment(Baseline to 6 months post-treatment)
- Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment(Baseline to 6 months post-treatment)
- Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment(Baseline to 6 months post-treatment)
- Responder Rate(Baseline to 6 months post-treatment)
研究者
Jayme Knutson
Senior Staff Scientist
MetroHealth Medical Center