跳至主要内容
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2024年3月29日

概览

阶段
不适用
干预措施
mirror therapy
疾病 / 适应症
Peripheral Nerve Injury
发起方
National Taiwan University Hospital
入组人数
7
试验地点
1
主要终点
change from baseline in corticomuscular coherence at week 12
状态
已完成
最后更新
3个月前

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: MT and CCFES group: mirror therapy combined with contralaterally controlled functional electrical stimulation Sham MT and CCFES group: Sham mirror therapy combined with contralaterally controlled functional electrical stimulation Control group: conventional physiotherapy. Each participant will receive conventional physiotherapy for 50 minutes daily, twice a week for 12 weeks. Conventional physiotherapy includes scar management, joint range of motion exercise, strengthening, stretching, and functional training. Participants in the MT and CCFES group or Sham MT and CCFES group will receive 30 minutes daily, twice a week of the intervention for 12 weeks in addition to the conventional physiotherapy. In the MT and CCFES group, the participants will sit in front of the mirror and watch the mirror reflection of the unaffected hands. At the same time, contralaterally controlled electrical stimulation will be conducted to make the affected hands move with the unaffected hands. The participants in the Sham MT and CCFES group will sit in front of the mirror without mirror reflection, but doing the exercise with contralaterally controlled functional electrical stimulation. All participants will receive the evaluations at baseline and 12 weeks after the intervention. The evaluations include: Electroencephalography of α and β bands from the sensorimotor cortices will be recorded. Electromyography will be performed during maximum isometric pinch or lateral pinch strength measurements. Maximum isometric grip strength, tip pinch strength, lateral pinch strength, sensation tests, and upper extremity function will be measured.

注册库
clinicaltrials.gov
开始日期
2024年3月29日
结束日期
2025年11月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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

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

干预措施: mirror therapy

MT and CCFES group

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

干预措施: contralaterally controlled functional electrical stimulation

MT and CCFES group

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

干预措施: conventional physiotherapy

Sham MT and CCFES group

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

干预措施: contralaterally controlled functional electrical stimulation

Sham MT and CCFES group

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

干预措施: conventional physiotherapy

Control group

conventional physiotherapy

干预措施: conventional physiotherapy

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)

研究点 (1)

Loading locations...

相似试验