Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test
研究概览
简要总结
This study tests the feasibility, safety and efficacy of garments embedding conductive electrodes (FES-shirt) for the independent delivery of functional electrical stimulation (FES). 12 people with SCI and 12 people with stroke who have some degree of arm paralysis will receive 40 hours of FES with these FES-shirt. The ability to use the FES-shirts and the improvement in function while receiving FES will indicate the immediate benefits. Their functional capabilities will be measured before and after 40 FES sessions to evaluate the carry-over effects.
详细描述
Spinal cord injury (SCI) and stroke can result in paralysis of arm and hand muscles preventing people from being able to use them in day to day activities, which can greatly impact quality of life. Functional electrical stimulation (FES) can activate the paralyzed muscles by sending a low energy electrical current through the skin. FES has been shown to improve the ability to control muscles in previous studies.In current simulators individual adhesive gel electrodes are positioned on the appropriate muscles to produce functional movements.This is time consuming and requires a therapist to guide electrode placement,besides the cables interfere with the individuals ability to perform functional movements with the FES.To approach this issue, we designed prototype shirts embedding all the necessary electrodes and wires to stimulate muscles around the hand, elbow and shoulder.
24 individuals with difficulty performing routine day to day activities with their upper extremities will be recruited to the study: 12 people with SCI and 12 people with stroke. Each participant will receive a custom designed FES shirt made based on individual participant body measurements and optimal electrode positions identified with standard gel electrodes.Study participants will receive 40 sessions of intervention, 3 to 5 times a week over 2 to 3 months. Each session will be one hour in duration and participant will receive functional electrical stimulation therapy through this customized shirt. They will have to don, activate, and doff the garment as independently as possible. The exercises conducted will be defined by the investigator based on the functional status of the participant and eventual progress.
Participants will be evaluated before and after the intervention using functional tests and questionnaires Participants will be invited to give their opinions on the shirt so that the researchers can improve its features.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking of the intervention to participant or assessor because there is only 1 arm.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete and Incomplete C4-C7 SCI or brain vascular stroke (hemorrhagic or ischemic)
- •Upper-limb paralysis to the extent that it interferes with the participants ability to perform activities of daily living independently.
- •More than 6 months post injury at the time of recruitment and should have been discharged from initial post-acute rehabilitation
- •Able to communicate verbally and read in English
排除标准
- •Implanted electronic devices such as: defibrillator, stimulator, insulin pump, baclofen pump, pace maker
- •Contracture and/or pain preventing shoulder elevation above 90 degrees.
- •Body mass index > 30 kg/m2 (severe obesity)
- •Known abdominal or aortic aneurysm
- •Known atrial of ventricular arrhythmia, unstable hypertension,
- •Diabetes with a history of recurrent hypoglycemic episodes
- •Cognitive impairments, such as co-morbid brain injury, depression, and/or mental illness preventing an active participation in the study
- •Known contact allergy to silver
- •Grade three pressure sore or cellulitis in the region intended to be tested
- •Body jewelry or tattoos in the area to be stimulated (between sites of the electrodes and/or at less than 2 inch distance from electrodes).
- •Specifically for participants with SCI:
- •Recurrent episodes of orthostatic hypotension preventing a prolonged seated position, or recurrent uncontrolled autonomic dysreflexia episodes
- •Prior history of myocardial infarction or stroke
- •Specifically for participants with Stroke:
- •Hemianopia, body hemineglect and/or aphasia preventing an efficient communication with researcher and interaction with the garment and the objects.
- •Prior history of spinal cord injury
结局指标
主要结局
Wolf Motor Function Test
时间窗: End study, after 14 weeks on average
For participants who had a stroke. A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success. Re-measured after the participant completed the 40 sessions
Toronto Rehabilitation Institute Hand Function Test
时间窗: End study, after 14 weeks on average
For participants who had a spinal cord injury. A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success. Re-measured after the participant completed the 40 sessions
次要结局
- Execution of the training tasks with FES(During the procedure)
- Functional Independence Measure (FIM)(End study, after 14 weeks on average)
- Execution of the training tasks without FES(During the procedure)
- Spinal Cord Independence Measure(End study, after 14 weeks on average)
- Grip strength(End study, after 14 weeks on average)
- Set-up time(During the procedure)
研究者
Milos Popovic
Research Director
Toronto Rehabilitation Institute