Posts Tagged Mirror therapy

[Abstract] THE EFFICACY OF MIRROR THERAPY IN ADDITION TO CONVENTIONAL THERAPY VERSUS CT ALONE IN THE ACUTE AND CHRONIC STAGES OF STROKE BASED ON THE ACTION RESEARCH AND ARM TEST: A META-ANALYSIS – Full Text PDF

ABSTRACT

Background: Stroke is one of the leading causes of long term disability for adults and costs the healthcare system 34 billion dollars annually.1-3 Directly after a stroke up to 85% of survivors have an impairment of the upper extremity.4 Previous research has shown mirror therapy (MT) is beneficial for improving function in the upper extremity.5-16

Objective: The objective of this meta-analysis was to determine the efficacy of MT in addition to conventional therapy (CT) versus CT alone in the different stages of stroke rehabilitation including the acute and chronic. 5,7-17

Methods: A literature review was conducted in the fall of 2018 and consisted of the following databases: Pubmed, Medline, and CINAHL. The studies were assessed and reviewed on the specified inclusion/exclusion criteria. A  fixed effect size model of 2 groups was used for the included studies to generate the Q-value, P-value, effect size, and confidence interval.

Results: The results favored MT in addition to CT as compared to CT alone in all stages of stroke rehabilitation. MT in addition to CT used in the acute stage of stroke rehabilitation was favored over MT in addition to CT used in the chronic stage of stroke rehabilitation.

Conclusion: This meta-analysis supports current literature that MT in addition to CT is more effective in improving upper extremity function than CT alone in all stages of stroke rehabilitation. The minimal to moderate effect found in the acute stage of stroke rehabilitation suggests that MT in addition to CT is more beneficial in the acute stage of stroke rehabilitation as compared to use in the chronic stage of stroke rehabilitation. The evidence should, however, be interpreted with caution until further studies are included.

Aaron Larson
May 2019

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[Abstract] Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review

Abstract

BACKGROUND:

Virtual reality (VR) has emerged as a therapeutic tool facilitating motor learning for balance and gait rehabilitation. The evidence, however, has not yet resulted in standardized guidelines. The aim of this study was to systematically review the application of VR-based rehabilitation of balance and gait in 6 neurologic cohorts, describing methodologic quality, intervention programs, and reported efficacy.

METHODS:

This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. VR-based treatments of Parkinson disease, multiple sclerosis, acute and chronic poststroke, traumatic brain injury, and cerebral palsy were researched in PubMed and Scopus, including earliest available records. Therapeutic validity (CONTENT scale) and risk of bias in randomized controlled trials (RCT) (Cochrane Collaboration tool) and non-RCT (Newcastle-Ottawa scale) were assessed.

RESULTS:

Ninety-seven articles were included, 68 published in 2013 or later. VR improved balance and gait in all cohorts, especially when combined with conventional rehabilitation. Most studies presented poor methodologic quality, lacked a clear rationale for intervention programs, and did not utilize motor learning principles meticulously. RCTs with more robust methodologic designs were widely recommended.

CONCLUSION:

Our results suggest that VR-based rehabilitation is developing rapidly, has the potential to improve balance and gait in neurologic patients, and brings additional benefits when combined with conventional rehabilitation. This systematic review provides detailed information for developing theory-driven protocols that may assist overcoming the observed lack of argued choices for intervention programs and motor learning implementation and serves as a reference for the design and planning of personalized VR-based treatments.

 

via Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review. – PubMed – NCBI

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[Abstract] How to perform mirror therapy after stroke? Evidence from a meta-analysis

Abstract

BACKGROUND:

A recently updated Cochrane review for mirror therapy (MT) showed a high level of evidence in the treatment of hemiparesis after stroke. However, the therapeutic protocols used in the individual studies showed significant variability.

OBJECTIVE:

A secondary meta-analysis was performed to detect which parameters of these protocols may influence the effect of MT for upper limb paresis after stroke.

METHODS:

Trials included in the Cochrane review, which published data for motor function / impairment of the upper limb, were subjected to this analysis. Trials or trial arms that used MT as group therapy or combined it with electrical or magnetic stimulation were excluded. The analysis focused on the parameters mirror size, uni- or bilateral movement execution, and type of exercise. Data were pooled by calculating the total weighted standardized mean difference and the 95% confidence interval.

RESULTS:

Overall, 32 trials were included. The use of a large mirror compared to a small mirror showed a higher effect on motor function. Movements executed unilaterally showed a higher effect on motor function than a bilateral execution. MT exercises including manipulation of objects showed a minor effect on motor function compared to movements excluding the manipulation of objects. None of the subgroup differences reached statistical significance.

CONCLUSIONS:

The results of this analysis suggest that the effects on both motor function and impairment of the affected upper limb depend on the therapy protocol. They furthermore indicate that a large mirror, unilateral movement execution and exercises without objects may be parameters that enhance the effects of MT for improving motor function after stroke.

 

via How to perform mirror therapy after stroke? Evidence from a meta-analysis. – PubMed – NCBI

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[Abstract + References] Investigation of the effects of mirror therapy on the spasticity, motor function and functionality of impaired upper limbs in chronic stroke patients

Background/Aims

Strokes lead to different levels of disability. During the chronic stage, hemiparesis, spasticity and motor deficits may cause loss of functional independence. Mirror therapy aims to reduce deficits and increase functional recovery of the impaired upper limb. This study aimed to evaluate the effects of mirror therapy on upper limb spasticity and motor function, as well as its impact on functional independence in chronic hemiparetic patients.

Methods

In this quasi-experimental study, eight chronic hemiparetic patients (age 55.5 ± 10.8 years) were assessed to determine their degree of spasticity (Modified Ashworth Scale), level of upper limb motor function (Fugl-Meyer Assessment) and functionality (Functional Independence Measure). All participants received 12 sessions of mirror therapy delivered three times per week, over a period of 4 weeks. Participants were re-evaluated post-intervention and these results were compared to their pre-intervention scores to determine the impact of mirror therapy.

Results

A decrease in spasticity was observed, with significant improvements in shoulder extensors (P=0.033) and a significant increase in motor function (P=0.002). The therapeutic protocol adopted did not have a significant effect on functional independence (P=0.105).

Conclusions

Mirror therapy led to improvements in upper limb spasticity and motor function in chronic hemiparetic stroke patients. No effects on functional independence were observed. Further research with a larger number of patients is needed to provide more robust evidence of the benefits of mirror therapy in chronic hemiparetic stroke patients.

 

References

via Investigation of the effects of mirror therapy on the spasticity, motor function and functionality of impaired upper limbs in chronic stroke patients | International Journal of Therapy and Rehabilitation

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[Abstract + References] Robotic hand system design for mirror therapy rehabilitation after stroke

Abstract

This paper developed a robotics-assisted device for the stroke patients to perform the hand rehabilitation. Not only the system can perform passive range of motion exercises for impaired hand, but also can perform mirror therapy for pinching and hand grasping motions under the guidance of the posture sensing glove worn on patient’s functional hand. Moreover, the framework and operation flow of the developed system has been and delineated in this paper. Practical results with human subjects are shown in this paper to examine the usability of proposed system, trial experiment of advance mirror therapy that use the proposed system to interact with realities is also presented in this paper.

References

  1. Bruder N (2010) Faculty of 1000 evaluation for Robot assisted therapy for long-term upper-limb impairment after stroke. F1000—post-publication peer review of the biomedical literatureGoogle Scholar
  2. Bullock IM et al (2012) Assessing assumptions in kinematic hand models: a review. In: 4th IEEE RAS/EMBS international conference on biomedical robotics and biomechatronicsGoogle Scholar
  3. Burgar CG et al (2011) Robot-assisted upper-limb therapy in acute rehabilitation setting following stroke: Department of Veterans Affairs multisite clinical trial. J Rehabil Res Dev 48:445–458CrossRefGoogle Scholar
  4. Dohle C et al (2009) Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair 23(3):209–217CrossRefGoogle Scholar
  5. Emerson et al (2016) Control Implementation for an Integrated robotic and virtual mirror therapy system for stroke rehabilitation. In 2016 IEEE 14th international workshop on advanced motion control (AMC)Google Scholar
  6. Hesse S et al (2006) Machines to support motor rehabilitation after stroke 10 years of experience in Berlin. J Rehabil Res Dev 53(5):671–678CrossRefGoogle Scholar
  7. Huang VS, Krakauer JW (2009) Robotic neurorehabilitation: a computational motor learning perspective. J NeuroEng Rehabil 5(6):5CrossRefGoogle Scholar
  8. Johansson BB (2000) Brain plasticity and stroke rehabilitation the Willis lecture. Stroke 31(1):223–230CrossRefGoogle Scholar
  9. Krebs HI et al (2008) A paradigm shift for rehabilitation robotics. IEEE Eng Med Biol Magn 27(4):61–70CrossRefGoogle Scholar
  10. Lo AC et al (2010) Robot-assisted therapy for long-term upper-limb impairment after stroke. New Engl J Med 362(19):1772–1783CrossRefGoogle Scholar
  11. Lum P, Burgar CG et al (2005) The mime robotic system for upper-limb neuro-rehabilitation: results from a clinical trial in subacute stroke. In: 9th International conference on rehabilitation robotics, pp 511–514Google Scholar
  12. Mendis S (2013) Stroke disability and rehabilitation of stroke: World Health Organization perspective. Int J Stroke 8(1):3–4CrossRefGoogle Scholar
  13. Morris C et al (2017) Low-cost assistive robot for mirror therapy rehabilitation. In: Proceedings of the 2017 IEEE international conference on robotics and biomimetics, pp 2057–2062Google Scholar
  14. Mukherjee D, Patil CG (2011) Epidemiology and the global burden of stroke. World Neurosurg 76(6):S85–S90CrossRefGoogle Scholar
  15. Narang G et al (2013) Use of unobtrusive human-machine interface for rehabilitation of stroke victims through robot assisted mirror therapy. In: Technologies for practical robot applications (TePRA), 2013 IEEE international conference on, pp 1–6Google Scholar
  16. Pérez-Cruzado D et al (2016) Systematic review of mirror therapy compared with conventional rehabilitation in upper extremity function in stroke survivors. Aust Occup Ther J 64(2):91–112CrossRefGoogle Scholar
  17. Pu S-W et al (2016) Anthropometry-based structural design of a hand exoskeleton for rehabilitation. In: 23rd International conference on mechatronics and machine vision in practice (M2VIP)Google Scholar
  18. Shahbazi M et al (2014) A framework for supervised robotics-assisted mirror rehabilitation therapy. In: 2014 IEEE/RSJ international conference on intelligent robots and systems (IROS 2014)Google Scholar
  19. Summers JJ et al (2007) Bilateral and unilateral movement training on upper limb function in chronic stroke patients: a TMS study. J Neurol Sci 252(1):76–82CrossRefGoogle Scholar
  20. Sydney Hand Surgery Pty Ltd (2017) Sydney hand surgery clinic. Available: http://www.sydneyhandsurgeryclinic.com.au/anatomy.asp. Accessed 2017
  21. Takeuchi N, Izumi S-I (2013) Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity. Stroke Res Treat 2013:1–13CrossRefGoogle Scholar

via Robotic hand system design for mirror therapy rehabilitation after stroke | SpringerLink

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[Abstract] Effect of Mirror Therapy on Recovery of Stroke Survivors: A Systematic Review and Network Meta-analysis.

Abstract

Mirror therapy (MT) as a relatively new rehabilitation technique has been widely applied in stroke patients. A number of randomized controlled trials (RCTs) have investigated the effects of MT for stroke survivors. The main purpose of this network meta-analysis was to investigate the effects of MT on motor function, activities of daily living (ADL), and pain perception in stroke survivors. Several databases were searched to identify RCTs evaluating the effects of MT in stroke patients to perform this network meta-analysis. Thirty-seven RCTs (42 analyses, 1685 subjects) were eligible for inclusion in the meta-analysis. Standard meta-analysis showed that MT significantly improved of motor function according to the increased Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), and decreased Modified Ashworth Scale (MAS) score. In addition, ADL was promoted by MT as the elevated Modified Barthel Index (MBI) and Motor Activity Log (MAL) score. Moreover, MT effectively relieved the pain of stroke patients as the Visual Analog Scale (VAS) score was reduced. Subgroup analyses and meta-regressions identified that the sources of heterogeneity might be different intervention arms and duration of interventions. Network meta-analysis showed that MT combined with electrical stimulation (ES) for less than 4 weeks along with conventional rehabilitation therapy (CT), and MT accompanied with CT for less than 4 weeks might be the most suitable interventions for improvement of motor function and ADL, respectively. Overall, MT could effectively improve motor function and ADL, as well as relieve pain for stroke survivors. The study was registered at PROSPERO (CRD42017081742).

PMID: 29981364 DOI: 10.1016/j.neuroscience.2018.06.044

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[NEWS] New Virtual Reality Therapy game could offer relief for patients with chronic pain, mobility issues

News-MedicalA Virtual Reality Therapy game (iVRT) which could introduce relief for patients suffering from chronic pain and mobility issues has been developed by a team of UK researchers.

Dr Andrew Wilson and colleagues from Birmingham City University built the CRPS app in collaboration with clinical staff at Sandwell and West Birmingham Hospitals NHS Trust for a new way to tackle complex regional pain syndrome and to aid people living with musculoskeletal conditions.

Using a head mounted display and controllers, the team created an immersive and interactive game which mimics the processes used in traditional ‘mirror therapy’ treatment. Within the game, players are consciously and subconsciously encouraged to stretch, move and position the limbs that are affected by their conditions.

Mirror therapy is a medical exercise intervention where a mirror is used to create areflective illusion that encourages patient’s brain to move their limb more freely. This intervention is often used by occupational therapists and physiotherapists to treat CRPS patients who have experienced a stroke. This treatment has proven to be successful exercises are often deemed routine and mundane by patients, which contributes to decline in the completion of therapy.

Work around the CRPS project, which could have major implications for other patient rehabilitation programmes worldwide when fully realised, was presented at the 12th European Conference on Game Based Learning (ECGBL) in France late last year.

Dr Wilson, who leads Birmingham City University’s contribution to a European research study into how virtual reality games can encourage more physical activity, and how movement science in virtual worlds can be used for both rehabilitation and treatment adherence, explained, “The first part of the CRPS project was to examine the feasibility of being able to create a game which reflects the rehabilitation exercises that the clinical teams use on the ground to reduce pain and improve mobility in specific patients.”

“By making the game enjoyable and playable we hope family members will play too and in doing so encourage the patient to continue with their rehabilitation. Our early research has shown that in healthy volunteers both regular and casual gamers enjoyed the game which is promising in terms of our theory surrounding how we may support treatment adherence by exploiting involvement of family and friends in the therapy processes.”

The CRPS project was realized through collaborative working between City Hospital, Birmingham, and staff at the School of Computing and Digital Technology, and was developed following research around the provision of a 3D virtual reality ophthalmoscopy trainer.

Andrea Quadling, Senior Occupational Therapist at Sandwell Hospital, said “The concept of using virtual reality to treat complex pain conditions is exciting, appealing and shows a lot of potential. This software has the potential to be very helpful in offering additional treatment options for people who suffer with CRPS.”

via New Virtual Reality Therapy game could offer relief for patients with chronic pain, mobility issues

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[Abstract] Immersive virtual reality mirror therapy for upper limb recovery following stroke – A pilot study

Abstract

Objective This study was designed to examine the feasibility of immersive virtual reality(VR) mirror therapy for upper limb paresis after stroke using a head-mounted display, and provide preliminary evidence of efficacy.

Design Ten outpatients with chronic stroke, upper limb hemiparesis, and a low predisposition for motion sickness completed a 12-session program of 30 minutes each of immersive VR mirror therapy. The VR system provided the illusion of movement in the hemiparetic upper limb while suppressing the visual representation of the non-paretic side. Feasibility was assessed via patient compliance, adverse event tracking, the System Usability Scale, and the Simulator Sickness Questionnaire. Preliminary efficacy was evaluated using the Fugl-Meyer Upper Extremity (FM-UE) and Action Research Arm Test.

Results Immersive VR mirror therapy for patients with chronic stroke was safe, well-tolerated, and without adverse events, such as simulator sickness. Motor outcomes revealed a small improvement for the FM-UE from 21.7 (SD= 8.68) to 22.8 (SD= 9.19) that did not achieve statistical significance (p=0.084).

Conclusion Four weeks of immersive virtual reality mirror therapy was well-tolerated by chronic stroke patients. Our findings support further clinical trials of immersive VR technologies and visually-enhanced mirror therapies for stroke survivors.

via Immersive virtual reality mirror therapy for upper limb reco… : American Journal of Physical Medicine & Rehabilitation

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[ARTICLE] Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial – Full Text

Abstract

Objective: The aim of this trial was to compare the effect of movement-based mirror therapy (MMT) and task-based mirror therapy (TMT) on improving upper limb functions in patients with stroke.

Methods: A total of 34 patients with sub-acute stroke with mildly to moderately impaired upper limb motor functions. The participants were randomly allocated to one of three groups: MMT, TMT, and conventional treatment (CT). The MMT group underwent movement-based mirror therapy for around 30 min/day, 5 days/week, for 4 weeks, whereas the TMT group underwent dose-matched TMT. The CT group underwent only conventional rehabilitation. The MMT and TMT groups underwent CT in addition to their mirror therapy. Blinded assessments were administered at baseline and immediately after the intervention. Upper limb motor functions, measured using Fugl-Meyer Assessment-upper extremity (FMA-UE), Wolf Motor Function Test (WMFT), and hand grip strength; upper limb spasticity, measured using the modified Ashworth scale (MAS); and activities of daily living, measured using the modified Barthel index (MBI).

Results: A significant time-by-group interaction effect was noted in FMA-UE. Post-hoc analysis of change scores showed that MMT yielded a better effect on improving FMA-UE than the other two therapies, at a marginally significant level (P = 0.050 and 0.022, respectively). No significant interaction effect was noted in WMFT, hand grip strength, MAS, and MBI.

Conclusion: Both MMT and TMT are effective in improving the upper limb function of patients with mild to moderate hemiplegia due to stroke. Nevertheless, MMT seems to be superior to TMT in improving hemiplegic upper extremity impairment. Further studies with larger stroke cohorts are expected to be inspired by this pilot trial.

Introduction

Mirror therapy (MT) has been shown to be a useful intervention for rehabilitation of upper limb functions following stroke, since the first attempt by Altschuler et al. (1). The neural correlate of MT remains under investigation. Three main theories explaining the neural mechanism underlying the clinical efficacy of MT have been proposed (2).

The first theory hypothesizes that the neural correlate of MT is the mirror neuron system (MNS), which is defined as a class of neurons that fire during action observation and action execution (3). It is assumed that the MNS can be triggered when people are observing mirror visual feedback (MVF) generated in MT (45). The affected cortical motor system can be accessed via the MNS owing to their functional connections (6). The second theory, supported by several studies with transcranial magnetic stimulation (TMS), suggests that a potential neural mechanism underlying the effect of MT can be the recruitment of the ipsilesional corticospinal pathway. Indeed, many TMS studies have demonstrated the increment of motor-evoked potentials of the ipsilesional primary motor cortex in participants with stroke when viewing MVF (7), which indicates a facilitatory effect of MVF on the ipsilesional corticospinal pathway. The last theory attributes the effect of MT to the compensation of restricted proprioception input from the affected limb and the enhancement of attention toward the paretic upper limb (8), which may contribute to the reduction of the learned non-use in patients with stroke (1).

A substantial number of randomized controlled trials (RCTs) have demonstrated that MT is useful in improving upper limb functions after stroke (912). A recently published meta-analytic review identified a moderate level of evidence supporting the effects of MT on improving upper limb motor functions (Hedges’ g = 0.47) and activities of daily living (ADLs) (Hedges’ g = 0.48) in patients with stroke (13). In the meta-analysis (13), the heterogeneity of conducting MT was obvious across studies. One major category of MT is movement-based MT (MMT), in which participants practice simple movements such as wrist flexion and extension, or finger flexion and extension, with their unaffected hands when viewing the MVF generated by a physical mirror placed at their mid-sagittal plane (1416). Another category of MT is task-based MT (TMT), in which participants perform specific motor tasks with their unaffected hands, such as squeezing sponges, placing pegs in holes, and flipping a card, while they are viewing the MVF (1217). In some studies, researchers applied MMT in the first few sessions and subsequently applied TMT in the following sessions, constituting a hybrid MT protocol (91018). MMT and TMT were also described as intransitive and transitive movements in some studies (910). However, a sub-group meta-analysis comparing MMT and TMT was not carried out in the meta-analysis study (13).

Initially, MMT was used for alleviating phantom pain after amputation and for treating upper limb hemiplegia after stroke (119). Subsequently, the effect of MMT in stroke upper limb rehabilitation has been systematically investigated by many clinical trials (141620). Arya et al. were the first to compare the effects of TMT with those of conventional rehabilitation on upper limb motor recovery after stroke, and they found a superior effect of TMT (12). The main rationale that Arya et al. mentioned was that the response of the MNS was better for object-directed actions than for non-object actions (1221). In a recent study comparing the effects of action observation training and MT on gait and balance in patients with stroke, the results showed that action observation training had significantly better effects on the improvement of balance functions than MT (22), indicating that action observation may be different from MT in terms of their neural mechanisms. In other studies in which TMT was introduced or combined with MMT, the authors did not explain why they employed TMT (911).

Thus far, no RCT has systematically investigated the difference between the effects of MMT and TMT. Therefore, we aimed to conduct an RCT to directly compare the effect of MMT and TMT, on improving hemiplegic upper limb motor functions, spasticity, and ADLs, in a group of patients with stroke.[…]

 

Continue —> Frontiers | Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial | Neurology

Figure 3. An example of the process of “fault and correction.” The given task is that participants are required to transfer an object placed in the No. 3 hole (in orange color) to the No. 2 hole (Step 1). However, participants usually move the object to the No. 4 hole when they are viewing the mirror reflection (Step 2). Then, participants realize the fault and transfer the object it to the No. 2 hole (Steps 3, 4).

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[Abstract] No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial.

Abstract

OBJECTIVE::

The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients.

DESIGN::

Assessor-blinded randomized controlled trial.

SETTING::

Inpatient rehabilitation clinic.

SUBJECTS::

A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident.

INTERVENTION::

The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion-extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation.

MAIN MEASURES::

Primary outcome includes Fugl-Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment.

RESULTS::

At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl-Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl-Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl-Meyer, nor for ARAT and FIM scores.

CONCLUSION::

Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

 

via No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial. – PubMed – NCBI

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