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Completed

NCT Number: NCT06209632

Mirror Therapy Combined With Contralaterally Controlled Functional Electrical Stimulation for Peripheral Nerve Injury

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mirror Therapy

Behavioral

30 minutes of intervention, twice a week, and a total of 12 weeks

Contralaterally Controlled Functional Electrical Stimulation

Device

30 minutes of intervention, twice a week, and a total of 12 weeks

Conventional Physiotherapy

Behavioral

50 minutes of intervention, twice a week, and a total of 12 weeks

Primary outcomes

  1. change from baseline in corticomuscular coherence at week 12

    Time frame: baseline, week 12

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

Secondary outcomes

  1. change from baseline in grip strength at week 12

    Time frame: baseline, week 12

    average grip strength measured for 3 times in killograms

  2. change from baseline in pinch strength at week 12

    Time frame: baseline, week 12

    average lateral pinch and palmar pinch measured for 3 times in killograms

  3. change from baseline in sensation on Semmes-Weinstein monofilament test at week 12

    Time frame: baseline, week 12

    force in grams

  4. change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire at week 12

    Time frame: baseline, week 12

    A total scale from 1 to 100. Higher scores indicate greater disability.

  5. change from baseline in maximum voluntary isometric contraction in surface EMG at week 12

    Time frame: baseline, week 12

    muscle activities of target muscles measured during pinch strength for 3 times in percentage

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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