FES-assisted Gait Training Intervention to Improve Gait in Individuals with an Incomplete Spinal Cord Injury - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of (Serious) Adverse Events [Safety of the Intervention]
研究概览
简要总结
A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.
详细描述
A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities, such as walking. These limitations are associated with muscle weakness, a disturbance of the reflex activity, and the inability or difficulty to recruit muscles below the lesion. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Studies that investigated the effect of locomotor training on a treadmill with functional electrical stimulation and/or body weight support (BWS) show improved function of the lower limbs. FES-assisted gait therapy may be a promising method for improving gait function in individuals with an incomplete SCI. Therefore, this study will investigate if an FES-assisted gait (with BWS) is feasible and safe. This study will also investigfate if an FES-assisted gait can improve gait function in people with an incomplete SCI.
Primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. The secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.
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
- •Have a non-progressive incomplete SCI.
- •Have limited motor abilities in the lower extremities.
- •Be able to walk on a treadmill for 30 minutes (with body weight support).
- •Be able to perform the 10 meter walk test overground with assistive devices and/or support form the researcher/physician.
- •Have a stable medical condition.
- •Have had the SCI for at least a year.
- •Be at least 18 years of age.
排除标准
- •Cardiac arrhythmias or cardiac disease;
- •Flaccid paralysis.
- •Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training;
- •A history of severe autonomic dysreflexia assessed with the 'Autonomic standards assessment';
- •Neurostimulator, pacemaker, or other device that prevents the safe use of electrical stimulation present in the body;
- •Very high sensitivity to electrical stimulation, i.e., sensitivity threshold is reached before motor responses are observed in all target muscles;
- •Insufficient mastery of the Dutch language (speaking and reading);
- •Severe cognitive or communicative disorders;
- •Being or becoming pregnant during the study period;
- •Severe psychiatric illness or disorders (at the discretion of the treating rehabilitation physician);
- •Involved in another intervention study which may have an effect on the outcome measures of the present study;
结局指标
主要结局
Incidence of (Serious) Adverse Events [Safety of the Intervention]
时间窗: Assessed during week 1 to 10 for each FES-assisted gait training session (2x week) and in week 0, week 11 and week 21 (during the pre-, post- and follow-up measurements)
The total number of (serious) adverse events
Feasibility of the intervention
时间窗: Assessed during week 11 during the post-intervention measurement.
Self-administered questionnaires about the training sessions, preceived effect, applicability of FES and the experience with walking with FES.
次要结局
- Change in muscle activity(Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11))
- Change in step length(Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11))
- Change in step width(Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11))
- Change in distance(Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week))
- Change in average and maximum treadmill walking speed(Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week))
- Change in average overground walking speed(Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11))
- Change in cadence(Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11))