Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mini-Balance Evaluation Systems Test
研究概览
简要总结
Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.
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
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
- •A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
- •≥18 years old;
- •Able to stand independently for 60s;
- •Moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and
- •Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).
排除标准
- •Severe spasticity in the legs;
- •Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
- •A prior lower extremity fragility fracture;
- •An injection of botulinum toxin to leg muscles in the past six months;
- •Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
- •A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; o
- •Contraindications for FES52 (i.e. implanted electronic device, active cancer or radiation in past 6 months, epilepsy, skin rash/wound at a potential electrode site).
- •Participants will be withdrawn from the study if FES irritates their skin.
结局指标
主要结局
Mini-Balance Evaluation Systems Test
时间窗: Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks
Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait
Activities-specific Balance Confidence Scale
时间窗: Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks
A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence)
Berg Balance Scale
时间窗: Change from Baseline Berg Balance Scale at 8 weeks
Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome
次要结局
- Static standing balance(Through study completion, average of 8 weeks)
- Dynamic standing balance(Through study completion, average of 8 weeks)
- Semi-structured interview(up to 8 weeks post-intervention)