Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial

Authors: Tsai-yu Shih, Ching-yi Wu, Keh-chung Lin, Chia-hsiung Cheng, Yu-wei Hsieh, Chia-ling Chen, Chih-jou Lai, Chih-chi Chen

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Loss of upper-extremity motor function is one of the most debilitating deficits following stroke. Two promising treatment approaches, action observation therapy (AOT) and mirror therapy (MT), aim to enhance motor learning and promote neural reorganization in patients through different afferent inputs and patterns of visual feedback. Both approaches involve different patterns of motor observation, imitation, and execution but share some similar neural bases of the mirror neuron system. AOT and MT used in stroke rehabilitation may confer differential benefits and neural activities that remain to be determined. This clinical trial aims to investigate and compare treatment effects and neural activity changes of AOT and MT with those of the control intervention in patients with subacute stroke.

Methods/design

An estimated total of 90 patients with subacute stroke will be recruited for this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (15 sessions). Outcome measurements will be taken at baseline, immediately after treatment, and at the 3-month follow-up. For the magnetoencephalography (MEG) study, we anticipate that we will recruit 12 to 15 patients per group. The primary outcome will be the Fugl-Meyer Assessment score. Secondary outcomes will include the modified Rankin Scale, the Box and Block Test, the ABILHAND questionnaire, the Questionnaire Upon Mental Imagery, the Functional Independence Measure, activity monitors, the Stroke Impact Scale version 3.0, and MEG signals.

Discussion

This clinical trial will provide scientific evidence of treatment effects on motor, functional outcomes, and neural activity mechanisms after AOT and MT in patients with subacute stroke. Further application and use of AOT and MT may include telerehabilitation or home-based rehabilitation through web-based or video teaching.

Trial registration

ClinicalTrials.gov, ID: NCT02871700. Registered on 1 August 2016.
Appendix
Available only for authorised users
Literature
1.
Duncan P, Studenski S, Richards L, Gollub S, Lai SM, Reker D, et al. Randomized clinical trial of therapeutic exercise in subacute stroke. Stroke. 2003;34:2173–80.CrossRefPubMed
2.
Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011;25:838–46.CrossRefPubMed
3.
Kwakkel G, Kollen BJ. Predicting activities after stroke: what is clinically relevant? Int J Stroke. 2013;8:25–32.CrossRefPubMed
4.
Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012;11:209.CrossRefPubMed
5.
Dobkin BH, Carmichael ST. The specific requirements of neural repair trials for stroke. Neurorehabil Neural Repair. 2016;30:470–8.CrossRefPubMed
6.
7.
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;29:349–61.CrossRefPubMed
8.
Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, et al. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36:T164–73.CrossRefPubMed
9.
Kim J, Lee B, Lee HS, Shin KH, Kim MJ, Son E. Differences in brain waves of normal persons and stroke patients during action observation and motor imagery. J Phys Ther Sci. 2014;26:215–8.CrossRefPubMedPubMedCentral
10.
Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall’Armi V, et al. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012;26:456–62.CrossRefPubMed
11.
Sugg K, Muller S, Winstein C, Hathorn D, Dempsey A. Does action observation training with immediate physical practice improve hemiparetic upper-limb function in chronic stroke? Neurorehabil Neural Repair. 2015;29:807–17.CrossRefPubMed
12.
Kim E, Kim K. Effects of purposeful action observation on kinematic patterns of upper extremity in individuals with hemiplegia. J Phys Ther Sci. 2015;27:1809–11.CrossRefPubMedPubMedCentral
13.
Sale P, Ceravolo MG, Franceschini M. Action observation therapy in the subacute phase promotes dexterity recovery in right-hemisphere stroke patients. Biomed Res Int. 2014;2014:457538.CrossRefPubMedPubMedCentral
14.
Cha YJ, Yoo EY, Jung MY, Park SH, Park JH, Lee J. Effects of mental practice with action observation training on occupational performance after stroke. J Stroke Cerebrovasc Dis. 2015;24:1405–13.CrossRefPubMed
15.
Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, et al. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999;353:2035–6.CrossRefPubMed
16.
Thieme H, Bayn M, Wurg M, Zange C, Pohl M, Behrens J. Mirror therapy for patients with severe arm paresis after stroke-a randomized controlled trial. Clin Rehabil. 2013;27:314–24.CrossRefPubMed
17.
Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013;94:1023–30.CrossRefPubMed
18.
Sathian K, Greenspan AI, Wolf SL. Doing it with mirrors: a case study of a novel approach to neurorehabilitation. Neurorehabil Neural Repair. 2000;14:73–6.CrossRefPubMed
19.
Molenberghs P, Cunnington R, Mattingley JB. Brain regions with mirror properties: a meta-analysis of 125 human fMRI studies. Neurosci Biobehav Rev. 2012;36:341–9.CrossRefPubMed
20.
21.
Buccino G, Binkofski F, Fink GR, Fadiga L, Fogassi L, Gallese V, et al. Action observation activates premotor and parietal areas in a somatotopic manner: an fMRI study. Eur J Neurosci. 2001;13:400–4.PubMed
22.
Cochin S, Barthelemy C, Roux S, Martineau J. Observation and execution of movement: similarities demonstrated by quantified electroencephalography. Eur J Neurosci. 1999;11:1839–42.CrossRefPubMed
23.
Iacoboni M, Woods RP, Brass M, Bekkering H, Mazziotta JC, Rizzolatti G. Cortical mechanisms of human imitation. Science. 1999;286:2526–8.CrossRefPubMed
24.
Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012;3:CD008449.
25.
Hamzei F, Lappchen CH, Glauche V, Mader I, Rijntjes M, Weiller C. Functional plasticity induced by mirror training: the mirror as the element connecting both hands to one hemisphere. Neurorehabil Neural Repair. 2012;26:484–96.CrossRefPubMed
26.
Matthys K, Smits M, Van der Geest JN, Van der Lugt A, Seurinck R, Stam HJ, et al. Mirror-induced visual illusion of hand movements: a functional magnetic resonance imaging study. Arch Phys Med Rehabil. 2009;90:675–81.CrossRefPubMed
27.
Cauraugh JH, Summers JJ. Neural plasticity and bilateral movements: a rehabilitation approach for chronic stroke. Prog Neurobiol. 2005;75:309–20.CrossRefPubMed
28.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7:13–31.PubMed
29.
Tsai CF, Lee WJ, Wang SJ, Shia BC, Nasreddine Z, Fuh JL. Psychometrics of the Montreal Cognitive Assessment (MoCA) and its subscales: validation of the Taiwanese version of the MoCA and an item response theory analysis. Int Psychogeriatr. 2012;24:651–8.CrossRefPubMed
30.
Maeda F, Kleiner-Fisman G, Pascual-Leone A. Motor facilitation while observing hand actions: specificity of the effect and role of observer’s orientation. J Neurophysiol. 2002;87:1329–35.CrossRefPubMed
31.
Hsieh YW, Wu CY, Lin KC, Chang YF, Chen CL, Liu JS. Responsiveness and validity of three outcome measures of motor function after stroke rehabilitation. Stroke. 2009;40:1386–91.CrossRefPubMed
32.
Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007;38:1091–6.CrossRefPubMed
33.
Uyttenboogaart M, Stewart RE, Vroomen PC, De Keyser J, Luijckx GJ. Optimizing cutoff scores for the Barthel Index and the modified Rankin Scale for defining outcome in acute stroke trials. Stroke. 2005;36:1984–7.CrossRefPubMed
34.
Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47:563–71.CrossRefPubMed
35.
Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985;39:386–91.CrossRefPubMed
36.
Penta M, Tesio L, Arnould C, Zancan A, Thonnard JL. The ABILHAND questionnaire as a measure of manual ability in chronic stroke patients: Rasch-based validation and relationship to upper limb impairment. Stroke. 2001;32:1627–34.CrossRefPubMed
37.
Wang TN, Lin KC, Wu CY, Chung CY, Pei YC, Teng YK. Validity, responsiveness, and clinically important difference of the ABILHAND questionnaire in patients with stroke. Arch Phys Med Rehabil. 2011;92:1086–91.CrossRefPubMed
38.
Sheehan PW. A shortened form of Betts’ Questionnaire upon mental imagery. J Clin Psychol. 1967;23:386–9.CrossRefPubMed
39.
Evans IM, Kamemoto WS. Reliability of the short form of Betts’ questionnaire on mental imagery: replication. Psychol Rep. 1973;33:281–2.CrossRef
40.
Hamilton BB, Granger CV, Sherwin FS, Zielezny M, Tashman JS. A uniform national data system for medical rehabilitation. In: Fuhrer MJ, editor. Rehabilitation outcomes: analysis and measurement. Baltimore: Paul H. Brookes Publishing Company; 1987. p. 137–47.
41.
Beninato M, Gill-Body KM, Salles S, Stark PC, Black-Schaffer RM, Stein J. Determination of the minimal clinically important difference in the FIM instrument in patients with stroke. Arch Phys Med Rehabil. 2006;87:32–9.CrossRefPubMed
42.
Wallace D, Duncan PW, Lai SM. Comparison of the responsiveness of the Barthel Index and the motor component of the Functional Independence Measure in stroke: the impact of using different methods for measuring responsiveness. J Clin Epidemiol. 2002;55:922–8.CrossRefPubMed
43.
Domene PA, Easton C. Combined triaxial accelerometry and heart rate telemetry for the physiological characterization of Latin dance in non-professional adults. J Dance Med Sci. 2014;18:29–36.CrossRefPubMed
44.
Gebruers N, Vanroy C, Truijen S, Engelborghs S, De Deyn PP. Monitoring of physical activity after stroke: a systematic review of accelerometry-based measures. Arch Phys Med Rehabil. 2010;91:288–97.CrossRefPubMed
45.
Duncan PW, Bode RK, Min Lai S, Perera S. Glycine Antagonist in Neuroprotection Americans (GAIN) Investigators. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003;84:950–63.CrossRefPubMed
46.
Cheng CH, Chan PY, Baillet S, Lin YY. Age-related reduced somatosensory gating is associated with altered alpha frequency desynchronization. Neural Plast. 2015;2015:302878.CrossRefPubMedPubMedCentral
Metadata
Title
Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial
Authors
Tsai-yu Shih
Ching-yi Wu
Keh-chung Lin
Chia-hsiung Cheng
Yu-wei Hsieh
Chia-ling Chen
Chih-jou Lai
Chih-chi Chen
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2205-z

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Research

The pathway to RCTs: how many roads are there? Examining the homogeneity of RCT justification

Study protocol

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

Letter

Response to letter to editor: ‘Comment on Arch et al., Trials. 2016;17:517’

Study protocol

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)

Study protocol

Acute effects of foam rolling on passive tissue stiffness and fascial sliding: study protocol for a randomized controlled trial

Study protocol

Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial