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临床试验/NCT06209632
NCT06209632已完成不适用

Effects of Mirror Therapy Combined With Contralaterally Controlled Functional Electrical Stimulation on Functional Recovery and Neuroplasticity in Patients With Peripheral Nerve Injury

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
change from baseline in corticomuscular coherence at week 12

研究概览

简要总结

The goal of this trial is to evaluate the effects of mirror therapy combined with contralaterally controlled functional electrical stimulation on motor recovery and neuroplasticity in patients with peripheral nerve injury. The main questions it aims to answer are Question 1: To compare corticomuscular coherence between the groups of mirror therapy combined with contralaterally controlled functional electrical stimulation, sham mirror therapy combined with contralaterally controlled functional electrical stimulation, and control group.

Question 2: To compare sensorimotor recovery between the groups of mirror therapy combined with contralaterally controlled functional electrical stimulation, sham mirror therapy combined with contralaterally controlled functional electrical stimulation, and control group.

Question 3: To evaluate the effects of each intervention on corticomuscular coherence and sensorimotor recovery 12 weeks post-intervention.

Participants will be asked to exercise their affected hand together with the unaffected hand while receiving contralaterally controlled electrical stimulation in front of the mirror or sham mirror. Researchers will compare the effects of mirror therapy combined with contralaterally controlled functional electrical stimulation on corticomuscular coherence and sensorimotor recovery with the other groups.

详细描述

The goal of this trial is to evaluate the effects of mirror therapy combined with contralaterally controlled functional electrical stimulation on motor recovery and neuroplasticity in patients with peripheral nerve injury. The main questions it aims to answer are:

Question 1: To compare corticomuscular coherence between the groups of mirror therapy combined with contralaterally controlled functional electrical stimulation, sham mirror therapy combined with contralaterally controlled functional electrical stimulation, and control group.

Question 2: To compare sensorimotor recovery between the groups of mirror therapy combined with contralaterally controlled functional electrical stimulation, sham mirror therapy combined with contralaterally controlled functional electrical stimulation, and control group.

Question 3: To evaluate the effects of each intervention on corticomuscular coherence and sensorimotor recovery 12 weeks post-intervention.

Eligible participants will be randomized into three groups:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed median or ulnar nerve transection injury of the forearm in the past 6 months
  • sufficient communication in the Chinese language
  • being able to follow instructions
  • the presence of target muscle denervation (e.g. muscle atrophy, inability to actively contract)
  • less than 10% surface EMG activity during pinch evaluation compared to the unaffected side

排除标准

  • had central nervous disease
  • had a recent (1 year) history of nerve entrapment syndrome
  • had a history of latent neuropathy, such as diabetes or dialysis

研究组 & 干预措施

MT and CCFES group

Experimental

mirror therapy combined with contralaterally controlled functional electrical stimulation to perform hand exercises

干预措施: mirror therapy (Behavioral)

MT and CCFES group

Experimental

mirror therapy combined with contralaterally controlled functional electrical stimulation to perform hand exercises

干预措施: contralaterally controlled functional electrical stimulation (Device)

MT and CCFES group

Experimental

mirror therapy combined with contralaterally controlled functional electrical stimulation to perform hand exercises

干预措施: conventional physiotherapy (Behavioral)

Sham MT and CCFES group

Sham Comparator

sham mirror therapy with contralaterally controlled functional electrical stimulation to perform hand exercises

干预措施: contralaterally controlled functional electrical stimulation (Device)

Sham MT and CCFES group

Sham Comparator

sham mirror therapy with contralaterally controlled functional electrical stimulation to perform hand exercises

干预措施: conventional physiotherapy (Behavioral)

Control group

Active Comparator

conventional physiotherapy

干预措施: conventional physiotherapy (Behavioral)

结局指标

主要结局

change from baseline in corticomuscular coherence at week 12

时间窗: baseline, week 12

coherence will be used to analyze the interaction between the electroencephalogram activation and electromyography activation

次要结局

  • change from baseline in pinch strength at week 12(baseline, week 12)
  • change from baseline in maximum voluntary isometric contraction in surface EMG at week 12(baseline, week 12)
  • change from baseline in grip strength at week 12(baseline, week 12)
  • change from baseline in sensation on Semmes-Weinstein monofilament test at week 12(baseline, week 12)
  • change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire at week 12(baseline, week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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