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临床试验/NCT05103436
NCT05103436进行中(未招募)不适用

Electrical Stimulation for Spasticity in Spinal Cord Injury

University of Alberta1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Change in Modified Ashworth Score

研究概览

简要总结

This study examines the immediate and long-term effects of lumbosacral TENS on spasticity and residual voluntary force control in spinal cord injury in comparison to no TENS. Participants in the intervention group will receive 2 months of TENS. Participants in the control group will receive TENS after a 2-month delay. Modified Ashworth score and pendulum test will be used to assess spasticity and force control. Electrophysiological measures will be used to assess the activity profile of motorneurons.

详细描述

Transcutaneous electrical nerve stimulation (TENS) has been used to control pain in stroke, MS, cerebral palsy and spinal cord injury (SCI) and its effect on spasticity reduction, although not used clinically, has been examined recently. In the few SCI studies done to date, the TENS electrodes have been placed on the nerve to the muscle under study and initial reports show a consistent decrease in spasticity measures, like the Modified Ashworth Score (MAS) and reflexes, during or hours after the TENS application. Recently, study team members from the ReYu Recovery Centre in Edmonton have observed that when TENS is applied with both electrodes over the lower back (lumbosacral TENS), varying amounts of immediate and long-term spasticity relief are produced in both legs.

The investigators have observed 3 clients from ReYU and all have shown immediate reductions in spasticity for at least 2 joints in both legs. The effect of the lumbosacral TENS varied from an immediate dramatic reduction to a more moderate reduction when applied over several days. This study will examine the immediate and longer-term (2 months) effect of using spinal TENS in reducing spasticity of the lower limbs in a larger number of participants with SCI. The investigators want to understand how spinal TENS affects spinal circuits and motoneurons below the lesion to reduce spasticity to observe improvement in its effect in those with more moderate responses. Lumbosacral TENS has the potential for a non-pharmacological, on-demand control of SCI spasticity to greatly improve the quality of life of those affected.

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
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

入选标准

  • SCI adults 18 years and older
  • injury levels between C5-T12

排除标准

  • severe head injury
  • uncontrolled autonomic dysreflexia
  • other medical conditions precluding TENS

结局指标

主要结局

Change in Modified Ashworth Score

时间窗: Pre Intervention. 1, 2 and 4 months follow up. In addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Clinical assessment of spasticity. Scores range from '0' to '4'. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome.

次要结局

  • Change in Knee Pendulum Angle(Pre Intervention. 1, 2 and 4 months follow up.)
  • Change in EMG(Pre Intervention. 1, 2 and 4 months follow up.)
  • Change in Manual Muscle Testing(Pre Intervention. 1, 2 and 4 months follow up.)
  • Change in International Standard for Neurological Classification of SCI (ISNCSI)(Pre Intervention. 1, 2 and 4 months follow up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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