RajivGandhiUniversity of Health Sciences, Karnataka,
Bangalore.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate & Address / N.SAI SRINIVASPlot no.117,H.no.5-4-1622/3
Narasimharao nagar
vanasthalipuram,
Hyderabad-500070
2. / Name of the Institution / K.T.G.COLLEGE OF PHYSIOTHERAPY
Hegganahalli Cross, Vishwaneedam Post,
Sunkadakatte via Magadi Road,
Bangalore-560091.
3. / Course of Study & Subject / MASTERS IN PHYSIOTHERAPY
(Neurological and psychosomatic disorders)
4. / Date of Admission to the Course / 18th June 2012
5 / Title of the Topic:
“EFFECT OF MIRROR THERAPY IN THE MANAGEMENT OF PAIN AND FUNCTION OF UPPER EXTREMITY WITHCOMPLEX REGIONAL PAIN SYNDROME TYPE 1 IN SUB ACUTE STROKEPATIENTS”.
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1.Need for the study:
Stroke is a major health problem in India.The average incidence rate of strokes in a recent study from kolkata was 145 per 100000 population which compares well with the well developed countries.Stroke burden has been rising in India as compared to the developed countries where it has reached plateau or decreased.1
The aim of any stroke rehabilitation is to counteract limitations in all areas of patient function,maximize patient ability to be independent and productive ,and improve quality of life.2
The natural history of stroke suggests that functional changes will vary over months and even years despite the fact that the greatest changes occur within the first 30 days post-stroke.There is no consensus as to how to classify the intervals of recovery following stroke.The definitions of acute,subacute and chronic stroke are arbitary and variable.For the purposes of review acute stroke is defined as 1 to 90 days ,subacute as 91 to 180 days and chronic stroke as greater than 180 days.2
The paretic upperlimb is a common and undesirable consequence of stroke that increases activity limitation .It has been reported that upto 85% of stroke survivors experience hemiparesis and that 55% percent to 75% of stroke survivors have continued to have limitations in upper extremity functioning.2
There are varying degrees of spontaneous improvement in arm paresis over the first 6 months after the stroke.The degree of improvement at 6 months is best predicted by the motor deficit at 1 month despite the standard rehabilitative interventions in the ensuing 5 months. 3
A number of interventions have been published evaluating the effect of various rehabilitation methods in improving upper-extremity motor control and functioning ,such as exercise training of the paretic arm,impairement-oriented training of the arm,functional electrical stimulation, robotic-assisted rehabilitation ,and bilateral arm training.However most of the treatment protocols for the paretic upper extremity are labor intensive and require one to one manual interaction with therapists for several weeks ,which makes provision of intensive treatment for all patients difficult.2
It has been suggested that Mirror Therapy is a simple ,inexpensive and most importantly,patient-directed treatment that may improve upper extremity function.Ramachandran and Rogers-ramachandran were the first to introduce the use of phantom limb pain.By superimposing the intact arm on the phantom limb using mirror reflection ,patients reported the sensation that they could move and relax the often-cramped phantom limb and experienced pain relief.Since this initial report ,successful use of mirror therapy has been reported in patients with other pain syndromes ,such as complex regional pain syndrome and in sensory re-education of severe hyperaesthesia after hand injuries.2
Complex Regional Pain Syndromes(CRPS) types I and II are neuropathic pain disorders that develop as an exaggerated response to a traumatic lesion or nerve damage,that generally affects the extremities or as a consequence of a distal process such as stroke ,spinal lesion or myocardial infarction.The onset and severity appears to be related with aetiology of stroke ,the severity and recovery of motor deficit,spasticity and sensory disturbances.4
In CRPS ,there is an exaggerated inflammatory response and some chemical mediators have been identified and are present in the inflammatory soup around the primary afferent fibres that through different process can induce hyperexcitability of the afferent fibres(Peripheral Sensitization).There is a localized neurogenic inflammation and is the basis of oedema,vasodilation and hyperhydrosis that are present in the initial phases.The repeated discharge of the C fibres causes an increased medullary excitability (Central Sensitization).4
Diagnosis of CRPS after stroke appears more complex than in other pathological situations,the paretic arm frequently appears painful,oedematose,with altered heat and tactile sensations and slightly dystrophic skin within a nonuse syndrome.Treatment may be non-pharmacological,pharmacological,with psychotherapy,regional anaesthesia ,neuromodulation and sympathectomy.4
Shrinkage of the cortial representation of the affected limb in the primary somatosensory cortex (Juottonen et al. 2002).and disrupted body schema (Schwoebel et al.2001)have been observed in CRPS I patients and post- stroke patients(Coslett,1998;Flor et al.1995;Grusser et.al.2001).It is notable that in both amputees with phantom pain and in stroke patients ,primary goal is to activate cortical areas that subserve the affected limb ,which leads to symptomatic and functional improvements(Flor et al;2001;Liepert et al.2000)and which inturn correlate with cortical reorganization.(Flor et al.2001;Kopp et al;1999).5
Mirror Therapy involves movement of the limb inside a mirror-box such that visual feed back of the affected hand is replaced with that of the (reflected)unaffected hand.Mirror Therapy is thought to reconcile motor output and sensory feedback (Ramachandran et al.1995)and activate premotor cortices (Seitz et al 1998),which have intimate connections with visual processing areas(di Pellegrino et al.1992).5
Previous studies in stroke ,although undersized and not sufficiently controlled,suggested that Mirror Therapy may be beneficial for motor function recovery in the paretic hand.2
Hence the aim of the present study is to find the effect of Mirror Therapy in the management of pain and function of upper extremity with Complex Regional Pain Syndrome Type I in Subacute Stroke patients.
Research Question:
Whether Mirror Therapy does have an effect in the management of pain and function of upper extremity with Complex Regional Pain Syndrome Type I in subacute stroke patients.
HYPOTHESIS
NullHypothesis:
There will be no significant effect of Mirror Therapy in the management of pain and function of upper extremity with Complex Regional Pain Syndrome Type I in subacute stroke patients.
Alternate Hypothesis:
There will be a significant effect of Mirror Therapy in the management of pain and function of upper extremity with Complex Regional Pain Syndrome Type I in subacute stroke patients.
Review of Literature:
Review on stroke :
- SV Khadilkar (2012) presented an article focusing on the current situation of common neurological diseases and also touch upon some aspects of the neurology health care and concluded that the diagnostic and therapeutic abilities of neurological physicians have gradually widened in present times , shortage of neurology work force, it’s uneven distribution , costs of neurology care are some of hindrances in providing the available facilities to the common Indian patient.
- Mark Oremus (2008) et.al prepared a report based on research of Methodological issues in evaluation of innovative training Approaches to stroke rehabilitation, as the basis for development of clinical practice guidelines and other quality enhancement tools as a basis or as a basis for reimbursement and coverage policies.
- Pertoldi S, (2005) et.al worked on CRPS type I and II stating that these are neuropathic pain disorders that develop as an exaggerated response to a traumatic lesion or nerve damage, that generally affects the extremities and have concluded that there is little evidence that supports the efficacy of the interventions normally used to treat or prevent CRPS. The key to effective treatment lies in an expert multidisciplinary team that is co-ordinated and motivated and that treats the disorder with individualized therapy.
- John W.Krakauer, M.D (2005) studied on recovery of arm function after stroke stating that cortical stimulation experiments in animals and functional imaging studies in humans indicate that motor learning and recovery after stroke share common brain reorganization mechanisms.Rehabiliatation techniques enhance learning-related changes after stroke and contribute to recovery.
- Gunes Yavuzer, MD, Ph D et.al (2008) have evaluated the effects of mirror therapy on upper extremity motor recovery, spasticity, and hand related functioning of in patients with sub acute stroke and concluded that hand functioning improved more after mirror therapy in addition to a conventional rehabilitation program and did not affect spasticity.
- Angelo Cacchio, MD (2009)have compared the effectiveness of mirror therapy on pain and function in CRPS type I in patients with acute stroke and found that mirror therapy effectively reduces pain and enhances upperlimb motor function in stroke patients with CPRS type I.
- Marian E.Michielsen, MSc et.al (2011) have evaluated the clinical effects of home – based mirror therapy and subsequent cortical reorganization in patients with chronic stroke with moderate upper extremity paresis and have concluded that there is some effectiveness for mirror therapy and is the first to associate mirror therapy with cortical reorganization.
- Denis Ertelt et.al (2007) have done combined observation of daily actions with concomitant physical training of the observed actions in a new neurorehabilitative program (action observation therapy) in stroke patients with moderate, chronic been motor deficit of upperlimb and have been concluded in pieces of evidence that action observation has a positive additional impact on recovery of motor function after stroke by reactivation of motor areas, which contain the action observation/action execution matching system.
9.Krutulyte G .et.al (2003) study was aimed to examine whether two (Bobath and Motor Relearning Program)different physiotherapy regimes caused any differences in outcome in the rehabilitation after stroke and found that physiotherapy with task-oriented strategies represented by Motor Relearning Program is preferable to physiotherapy with facilitation/inhibition strategies.
10.Dora YL Chan .et al (2006) have studied the efficacy of the motor relearning approach in promoting physical function and task performance for patients after a stroke and found that Motor Relearning Program is effective for enhancing functional recovery.
Review on Brunnstrom Recovery stages :
11.Naghdi S et.al (2010) have studied the extent to which the Brunnstrom recovery stages of upperlimb in hemiparetic stroke patients are correlated to neurophysiological measures and the spasticity Measure of Modified Ashworth Scale (MMAS) and found that the Brunnstrom recovery stages are moderately correlated with neurophysiological measures and highly correlated with the MMAS regarding the evaluation of motor recovery in stroke patients. And the same can be used as a valid test for the assessment of patients with post-stroke hemiplegia.
Review on Visual Analog Scale :
12.Boonstra AM et.al (2008) have studied the reliability and concurrent validity of a Visual Analog Scale for disability as a single item instrument measuring disability in chronic pain patients and found that the reliability of the VAS for disability is moderate to good.
Review on Motor Activity Log :
Uswatte G et.al (2005) have done research on the MAL during study in CIMT and is used how stroke survivors use their more-impaired arm outside the laboratory, and the article examined the psychometrics of the 14 item version of thisinstrument in 2 chronic stroke samples with mild to moderate upper extremity hemiparesis found that MAL Quality Of Measurement scale can be used exclusively to reliably and validy measure in real-world.
Review on Mini Mental State Examination:
Tombaugh, Tom N.; McIntyre, Nancy J(1992) Summarizes findings over the past 26 yrs
regarding the psychometric properties and utility of the Mini-Mental State Examination
(MMSE). The reviewed studies assessed a wide variety of Ss, ranging from cognitively
intact Ss to those with severe cognitive impairment associated with various dementing illnesses.
Reliability and construct validity were judged to be satisfactory.
6.3 Objectives of the Study:
The objectives of the study are:
- To measure the relief of pain in CRPS type I upper limb pre and post treatment in Experimental (mirror therapy )group and Control group.
- To measure the functional improvement in CRPS type I upper limb pre and post treatment in Experimental(mirror therapy)group and Control group.
- To compare the pain reliefin CRPS type I upper limb pre and post treatment between Experimental(mirror therapy) and Control group.
- The compare the functional improvement in CRPS type I upper limb pre and post treatment between Experimental(mirror therapy) and Control group.
7.1 Study Design:
Experimental study design with two groups – Experimental (Mirror Therapy) Group and Control Group.
7.2 Methodology:
Study Subject:
Subjects with sub-acute stroke within 4 weeks
Sample Size:
Study will be done on 30 subjects (15 in Experimental(Mirror Therapy) Group and 15 in Control Group).
Study setting and source of data:
Study will be conducted in K.T.G.Hospital, NIMHANS Bangalore and other Rehabilitation centers.
Sampling Method:
Simple random sampling method.
Study Duration:
4 weeks study.
Sample Selection:
Random Sampling
Inclusion Criterion:
- Subjects with the first episode of Unilateral stroke with hemiparesis during the previous six months
- Diagnosis of CRPS I based on diagnostic criterion.
- Visual Analog Scale (VAS 0-10cm) pain score>4.
- Demonstration of Brunnstrom stage equal to or below stage III of the affected upper extremity.
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments.
- No excessive spasticity in any of the joints of the affected UL Subjects with intact communicative skills and co-operative.
- Any intra articular injection into the affected shoulder during the previous 6 months or use of systemic corticosteroids during the previous 4 months.
- The presence of another obvious explanation for the pain (eg. fracture, radiculopathy)
- Prior surgery to either the shoulder or neck region.
- Serious uncontrolled medical conditions.
- Global aphasia and cognitive impairments that might interfere with understanding instructions for VAS, motor testing and treatment.
- Visual impairments that might interfere with the aims of the study.
- Evidence of recent alcohol or drug abuse or severe mental depression.
- Mirror board ( 70-120cm)
- A piece of Cotton and blunt object
- A sheet of paper (70-120cm)
- All the equipment required for 14 step Motor Activity Log.
- Visual Analog Scale (VAS)
- Motor Activity Log (MAL)
- Intervention to both Experimental Group A and Control group B:
- Both the groups will receive 4 week conventional stroke rehabilitation program, consisting of five 1 hour session a week
- The conventional program is patients specific and consists of Neuro-rehabilitation techniques, Occupational therapy and speech therapy.
- The Experimental group received an additional 30 minutes (for the first 2 weeks) and 1 hour (for the last 2 weeks) per session of a mirror therapy program consisting of unaffected upper limb movements.
- Patients were seated on a chair, with a mirror board (70 -120cm) positioned between the upper limbs perpendicular to the subjects midline and with the unaffected upper limb facing the reflective surface.
- Under the supervision the patient observes the reflection of their unaffected upper limb while performing the following movements: flexion, extension of the shoulder, elbow and wrist and pronation and supination of the forearm.
- The speed of the movements will be self selected and additional verbal feedback wouldn’t be offered.
- The control group performed the same exercise for the same duration, but reflecting part of the mirror will be covered with paper. No analgesic drug for pain relief will be administered to the patients during the study period.
- Statistical analysis will be performed by using SPSS software for window (version 16) and p-value will be set as 0.05.
- Descriptive statistics and chi-square test will be used to analyse the base line data for demographic data.
- Unpaired t-test and Wilcoxon signed ranked test will be used to find the significance of parameters.
- Independent t-test and Mann-Whitney U test will be used to analysis the variables between the groups.
As the study includes human subjects ethical clearance has been obtained from the ethical committee of K.T.G college of Physiotherapy, Bangalore as per the ethical guidelines for Bio-medical research on human subjects,2000 ICMR, New Delhi. Also a written consent will be taken from each subject who participates in the study.
List of References:
- S.V.Khadilkar, “Neurology : The Scenario in India”, JAPI, January 2012, Vol-60.
- Mark Oremus et.al “Methodological Issues in Evaluation of Innovative Training Approaches to stroke rehabilitation : Technology Assessment Report”,November-17,2008.
- Gunes Yavuzer, MD. Phd. et…al “Mirror Therapy improves hand function in sub-acute stroke : A Randomized controlled Trial”, Arch Phys Med Rehabil, March 2008, Volume 89.
- Petroldi S et.al, “Shoulder Hand Syndrome after stroke. A complex Regional pain syndrome”. Europa Medico physica, 2005, 41 (4), 283-292.
- G.L.Moseley et.al , “ Graded motor imagery is effective for long-standing complex Regional pain syndrome : A randomized controlled trial” January 2004, pain 108, 192-198.
- John W.krakauer, M.D et.al “ Arm Function after stroke : From physiology to recovery” “Seminars in Neurology / November 4,2005/Volume 25.
- Angelo Cacchio, MD et.al “Mirror Therapy in complex Regional pain syndrome type I of the upper limb in stroke patients” Neurorehabilitation and Neural Repair,2009.
- Marian E.Michielsen, Msc et.al “Motor Recovery and cortical Reorganisation. After Mirror Therapy in Chronic stroke patients : A phase II Randomised controlled Trial”, “Neurorehabilitation and Neural Repair, March/April 2011, Vol,25, no.3, 223-233.
- Denis Ertelt et.al “observation and Execution of upper limb movements as a tool forrehabilitation of motor deficits in paretic stroke patients : Protocol of a randomized clinical trial “BMC Neurology 2012, 12:42.
- Krutulyte G et.al. “The Effectiveness of physical Therapy methods (Bobath and motor relearning program) in rehabilitation of stroke patients”, Medicina (Kaunas) 2003, 39(9), 889-95.
- Dora YL chan….et.al “Motor relearning programme for stroke patients a randomized controlled trial”, clinical rehabilitation, March 2006, volume 20, no.3, 191-200.
- Giraux P.et.al “Illusory movements of the paralyzed limb restore motor cortex activity “Neuroimage, 2003 ; 20 (suppl 1) : (07-11)
- Naghdi S et.al “A Neurophysiological and clinical study of Brunnstrom recovery stages in the upperlimb following stroke, 2010, vol.24, No.11, pages ; 1372-1378.
- Boonstra AM et.al, “Reliability and Validity of the Visual analogue scale for disability in patients with chronic musculoskeletal pain”, International Journal of Rehabilatation Research ,June 2008, volume 31, Issue 2, PP 165-169.
- Uswatte G.Phd et.al, “Reliability and validity of the upper-extremity Motor Activity Log-14 for Measuring Real-world Arm Use”, stroke.2005 ,36, 2493-2496.
- Kwakkel G. et.al “Intensity of leg and arm training after primary middle cerebral-Artery stroke ; a randomized trial” 1999; 17; 191-6.
- Ramachandran Vs et.al ; “synaesthesia in Phantom limb induced with mirrors” proc R Soc Lond B Biol Sci 1996; 263; 377-86.
- McCabe CS et.al; “A controlled pilot study of the utility of mirror visual feedback in the treatment of complex Regional pain syndrome (type 1), 2003, 42;97-101.
9. / Signature of Candidate
10. / Remarks of the Guide
11. / Name and Designation of
11.1 Guide :
11.2 Signature
11.3 Co-Guide :
11.4 Signature
11.5Head of Department :
11.6 Signature
12. / 12.1Remarks of the Chairman & Principal
12.2Signature
ANNEXURE -1