Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Box and Block Test Score
研究概览
简要总结
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
详细描述
A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
- •age 21-80 years old
- •unilateral upper limb hemiparesis with finger extensor strength of grade <=4/5 on the Medical Research Council (MRC) scale AND a score of >=1 and <=11/14 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 2 of 3 words after 30 minutes
- •surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)
- •Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects
- •intact vision and hearing
- •medically stable
- •full voluntary opening/closing of the contralateral (less affected) hand
- •demonstrate 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
- •severely impaired cognition and communication
- •uncompensated hemineglect
- •arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)
- •insensate forearm (to avoid risk of electrical burns)
- •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 stimulation during pregnancy
- •participating in occupational therapy or other rehabilitation therapies to the upper extremity
- •severe shoulder or hand pain
结局指标
主要结局
Box and Block Test Score
时间窗: 0 weeks,12 weeks, 36 weeks
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
次要结局
- Action Research Arm Test (ARAT) Score(0 weeks, 12 weeks, 36 weeks)