NCT06209632

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 3, 2024

Last Update Submit

January 12, 2026

Conditions

Keywords

mirror therapyelectrical stimulationneuroplasticityperipheral nerve injury

Outcome Measures

Primary Outcomes (1)

  • change from baseline in corticomuscular coherence at week 12

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

    baseline, week 12

Secondary Outcomes (5)

  • change from baseline in grip strength at week 12

    baseline, week 12

  • change from baseline in pinch 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

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

    baseline, week 12

Study Arms (3)

MT and CCFES group

EXPERIMENTAL

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

Behavioral: mirror therapyDevice: contralaterally controlled functional electrical stimulationBehavioral: conventional physiotherapy

Sham MT and CCFES group

SHAM COMPARATOR

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

Device: contralaterally controlled functional electrical stimulationBehavioral: conventional physiotherapy

Control group

ACTIVE COMPARATOR

conventional physiotherapy

Behavioral: conventional physiotherapy

Interventions

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

MT and CCFES groupSham MT and CCFES group

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

Control groupMT and CCFES groupSham MT and CCFES group
mirror therapyBEHAVIORAL

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

MT and CCFES group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (14)

  • 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.

    PMID: 35657095BACKGROUND
  • 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.

    PMID: 32848663BACKGROUND
  • 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.

    PMID: 25160567BACKGROUND
  • 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.

    PMID: 29230518BACKGROUND
  • 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.

    PMID: 29853839BACKGROUND
  • 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.

    PMID: 27011016BACKGROUND
  • 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.

    PMID: 23474778BACKGROUND
  • 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.

    PMID: 34875363BACKGROUND
  • 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.

    PMID: 29993119BACKGROUND
  • 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.

    PMID: 27476437BACKGROUND
  • 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.

    PMID: 32830512BACKGROUND
  • 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.

    PMID: 37341447BACKGROUND
  • 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.

    PMID: 35574940BACKGROUND
  • 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.

    PMID: 36550934BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Yueh-Hsia Chen, PhD

    National Taiwan University, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 17, 2024

Study Start

March 29, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations