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

Peripheral Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209632
• Other study ID #: 202309076RINA
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Yueh-Hsia Chen, PhD
• Phone: +886-3366-8133
• Email: yuehhsiachen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 31, 2027
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Wounds and Injuries

Intervention

Behavioral:
• mirror therapy
30 minutes of intervention, twice a week, and a total of 12 weeks

Device:
• contralaterally controlled functional electrical stimulation
30 minutes of intervention, twice a week, and a total of 12 weeks

Behavioral:
• conventional physiotherapy
50 minutes of intervention, twice a week, and a total of 12 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Jun 21:1-7. doi: 10.1080/09638288.2023.2225878. Online ahead of print. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from baseline in grip strength at week 12	average grip strength measured for 3 times in killograms	baseline, week 12
Secondary	change from baseline in pinch strength at week 12	average lateral pinch and palmar pinch measured for 3 times in killograms	baseline, week 12
Secondary	change from baseline in sensation on Semmes-Weinstein monofilament test at week 12	force in grams	baseline, week 12
Secondary	change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire at week 12	A total scale from 1 to 100. Higher scores indicate greater disability.	baseline, week 12
Secondary	change from baseline in maximum voluntary isometric contraction in surface EMG at week 12	muscle activities of target muscles measured during pinch strength for 3 times in percentage	baseline, week 12