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

NCT ID: NCT06209632

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peripheral Nerve Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MT and CCFES group

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

Group Type EXPERIMENTAL

contralaterally controlled functional electrical stimulation

Intervention Type DEVICE

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

conventional physiotherapy

Intervention Type BEHAVIORAL

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

mirror therapy

Intervention Type BEHAVIORAL

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

Sham MT and CCFES group

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

Group Type SHAM_COMPARATOR

contralaterally controlled functional electrical stimulation

Intervention Type DEVICE

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

conventional physiotherapy

Intervention Type BEHAVIORAL

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

Control group

conventional physiotherapy

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type BEHAVIORAL

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

Interventions

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contralaterally controlled functional electrical stimulation

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

Intervention Type DEVICE

conventional physiotherapy

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

Intervention Type BEHAVIORAL

mirror therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yueh-Hsia Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University, School of Medicine

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Rizzo M, Petrini L, Del Percio C, Lopez S, Arendt-Nielsen L, Babiloni C. Mirror visual feedback during unilateral finger movements is related to the desynchronization of cortical electroencephalographic somatomotor alpha rhythms. Psychophysiology. 2022 Dec;59(12):e14116. doi: 10.1111/psyp.14116. Epub 2022 Jun 3.

Reference Type BACKGROUND
PMID: 35657095 (View on PubMed)

Bello UM, Kranz GS, Winser SJ, Chan CCH. Neural Processes Underlying Mirror-Induced Visual Illusion: An Activation Likelihood Estimation Meta-Analysis. Front Hum Neurosci. 2020 Jul 31;14:276. doi: 10.3389/fnhum.2020.00276. eCollection 2020.

Reference Type BACKGROUND
PMID: 32848663 (View on PubMed)

Deconinck FJ, Smorenburg AR, Benham A, Ledebt A, Feltham MG, Savelsbergh GJ. Reflections on mirror therapy: a systematic review of the effect of mirror visual feedback on the brain. Neurorehabil Neural Repair. 2015 May;29(4):349-61. doi: 10.1177/1545968314546134. Epub 2014 Aug 26.

Reference Type BACKGROUND
PMID: 25160567 (View on PubMed)

Cengiz B, Vuralli D, Zinnuroglu M, Bayer G, Golmohammadzadeh H, Gunendi Z, Turgut AE, Irfanoglu B, Arikan KB. Analysis of mirror neuron system activation during action observation alone and action observation with motor imagery tasks. Exp Brain Res. 2018 Feb;236(2):497-503. doi: 10.1007/s00221-017-5147-5. Epub 2017 Dec 11.

Reference Type BACKGROUND
PMID: 29230518 (View on PubMed)

Zhang JJQ, Fong KNK, Welage N, Liu KPY. The Activation of the Mirror Neuron System during Action Observation and Action Execution with Mirror Visual Feedback in Stroke: A Systematic Review. Neural Plast. 2018 Apr 24;2018:2321045. doi: 10.1155/2018/2321045. eCollection 2018.

Reference Type BACKGROUND
PMID: 29853839 (View on PubMed)

Gatti R, Rocca MA, Fumagalli S, Cattrysse E, Kerckhofs E, Falini A, Filippi M. The effect of action observation/execution on mirror neuron system recruitment: an fMRI study in healthy individuals. Brain Imaging Behav. 2017 Apr;11(2):565-576. doi: 10.1007/s11682-016-9536-3.

Reference Type BACKGROUND
PMID: 27011016 (View on PubMed)

Wang J, Fritzsch C, Bernarding J, Holtze S, Mauritz KH, Brunetti M, Dohle C. A comparison of neural mechanisms in mirror therapy and movement observation therapy. J Rehabil Med. 2013 Apr;45(4):410-3. doi: 10.2340/16501977-1127.

Reference Type BACKGROUND
PMID: 23474778 (View on PubMed)

Chen YH, Siow TY, Wang JY, Lin SY, Chao YH. Greater Cortical Activation and Motor Recovery Following Mirror Therapy Immediately after Peripheral Nerve Repair of the Forearm. Neuroscience. 2022 Jan 15;481:123-133. doi: 10.1016/j.neuroscience.2021.11.048. Epub 2021 Dec 5.

Reference Type BACKGROUND
PMID: 34875363 (View on PubMed)

Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.

Reference Type BACKGROUND
PMID: 29993119 (View on PubMed)

Willand MP, Rosa E, Michalski B, Zhang JJ, Gordon T, Fahnestock M, Borschel GH. Electrical muscle stimulation elevates intramuscular BDNF and GDNF mRNA following peripheral nerve injury and repair in rats. Neuroscience. 2016 Oct 15;334:93-104. doi: 10.1016/j.neuroscience.2016.07.040. Epub 2016 Jul 29.

Reference Type BACKGROUND
PMID: 27476437 (View on PubMed)

Saavedra-Garcia A, Moral-Munoz JA, Lucena-Anton D. Mirror therapy simultaneously combined with electrical stimulation for upper limb motor function recovery after stroke: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2021 Jan;35(1):39-50. doi: 10.1177/0269215520951935. Epub 2020 Aug 24.

Reference Type BACKGROUND
PMID: 32830512 (View on PubMed)

Zhang Y, Zhang X, Cheng C, Huang S, Hua Y, Hu J, Wang Y, Zhang W, Yang Y, Liu Y, Jia J, Gou P, Zhang P, Zhou F, Wei X, Bai Y. Mirror therapy combined with contralaterally controlled functional electrical stimulation for the upper limb motor function after stroke: a randomized controlled trial. Disabil Rehabil. 2024 Jun;46(12):2528-2534. doi: 10.1080/09638288.2023.2225878. Epub 2023 Jun 21.

Reference Type BACKGROUND
PMID: 37341447 (View on PubMed)

Loh MS, Kuan YC, Wu CW, Liao CD, Hong JP, Chen HC. Upper Extremity Contralaterally Controlled Functional Electrical Stimulation Versus Neuromuscular Electrical Stimulation in Post-Stroke Individuals: A Meta-Analysis of Randomized Controlled Trials. Neurorehabil Neural Repair. 2022 Jul;36(7):472-482. doi: 10.1177/15459683221092647. Epub 2022 May 16.

Reference Type BACKGROUND
PMID: 35574940 (View on PubMed)

Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727.

Reference Type BACKGROUND
PMID: 36550934 (View on PubMed)

Other Identifiers

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202309076RINA

Identifier Type: -

Identifier Source: org_study_id

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