Master of Physiotherapy in Neurological and Psychosomatic Disorders

RESEARCH PROPOSAL

TO TEST THE EFFECT OF ELECTRICAL STIMULATION IN ACUTE STROKE AND TO FIND CORRELATION BETWEEN STIMULATION DOSAGE AND MOTOR RECOVERY BY FINDING THE LEAST EFFECTIVE DOSE.

MASTER OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS.

MS.KAMAT MEGHA VIJAYENDRA

DEPARTMENT OF PHYSIOTHERAPY

FATHERMULLERMEDICALCOLLEGE

MANGALORE-575002

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / MS. KAMAT MEGHA VIJAYENDRA
DEPARTMENT OF PHYSIOTHERAPY
FATHER MULLER MEDICALCOLLEGE
MANGALORE-575002
2. / NAME OF THE INSTITUTION / FATHERMULLERMEDICALCOLLEGE
MANGALORE
3. / COURSE OF THE STUDY / MASTER OF PHYSIOTHERAPY IN NEULOGICAL AND PSYCHOSOMATIC DISORDERS.
4. / DATE OF ADMISSION TO THE COURSE / 01-06-2011
5. / TITLE OF THE TOPIC / TO TEST THE EFFECT OF ELECTRICAL STIMULATION IN ACUTE STROKE AND TO FIND CORRELATION BETWEEN STIMULATION DOSAGE AND MOTOR RECOVERY BY FINDING LEAST EFFECTIVE DOSE.
/ BRIEF RESUME OF THE INTENDED WORK.
6.1 NEED FOR THE STUDY:
A large percentage of stroke patients are left with residual deformity in their limbs which hampers their ADL’s. The “gold standard” intervention for treatment of impairment in stroke has not been met andlow-cost treatment if found would reduce functional impairmentand disability in strokepatients1 .
Results suggest that, after local damage to the motor cortex, rehabilitativetraining shapes subsequent reorganization in the adjacent intact cortex hence the undamaged motor cortex may play an important role in motorrecovery2.
A significant number of post-stroke subjects rated their recovery as low and this subjective analysis of well being was linked to motor recovery. An effective Intervention targeting motor recovery early post stroke would improve the patients perception of their recovery3.
Evidence supports the use of neuromuscular electrical stimulation to facilitate motor recovery of and coordination in hemiplegia. However, effects on physical disability are uncertain4.
It is proven that somatosensory stimulation (NMES) to the peripheral nerve produces changes in cortical excitability. These findings suggest that NMES (neuro muscular electrical stimulation)has an important role in stimulating cortical sensory areas for improved motor function5.More than 50 % of Stroke survivors have reported impairment of hand function past the predicted recovery period. Electrical stimulation has shown beneficial effects in upper limb function recovery5. A recent study using NMES to the affected upper extremity (UE) of stroke patients, improves motor recovery and effect persists for 3 months thus emphasizing carry-over effects of ES6.
Studies have been performed in stroke subjects to evaluate the relationship of stimulationparameters of electrical stimulation to the therapeutic outcome. Tentative correlation has been attributed to effect of frequency, amplitude, pulse duration. The role of the treatment duration remains hazy7.
Studies performed in post stroke subjects stimulating wrist extensors for 30 minutes, 3 times in a day using NMES:
1)Powell et al used a NMES frequency of 20 Hertz and pulse duration of 300µs for 8 weeks1.
2) Baker et al performed a study7 days per week, 4 weeks using NMES frequency:33 hertz, amplitude: 0–100 mA and pulse duration: 200 µs8.
Studies performed in post-stroke subjects using 60 minutes duration and stimulating wrist extensors 3 times a day for 7 days per week:
1)De Kroon et al performed a study for 6 weeks using NMES, frequency: 36 Hertz, Amplitude 0–60 mA , pulse duration 50–500µs9.
2)Hendricks et al performed a study for 10 weeks using NMES, frequency: 36 Hertz and pulse
duration: 100–500µs10.
The above studies did not establish relationship of motor recovery to treatment duration while demonstrating motor recovery. None of the above studies was performed in acute stroke7.
Durations used in previous studies (30 minutes and 60 minutes) Did not yield evidence to relate motor recovery to duration of stimulation.Determination of the minimal effective dose would aid relegation of appropriate dose distribution11.
Extensive literature search indicates less number of studies performed in acute stroke. There is also a lack in studies citing guidelines for dose relegation in acute stroke. Hence this study will utilize two dose parameters taken within the duration most frequently used: 30 minutes and 60 minutes stimulating wrist extensors in acute post-stroke casesusing NMES and attempt torelate these duration parameters to motor recovery by determining the minimal effective dose.
Previous studies using NMES, stimulating wrist extensors in acute stroke while demonstrating motor improvement have not been able to attribute functional recovery to ES5. Here lies the need to prove that motor recovery and functional recovery following ES parallel each other by early and repeated evaluation of functional capacity, evaluated by administration of the Barthel index and ARAT (Action research Arm Test).
RESEARCH QUESTIONS:
Does electrical stimulation produce motor recovery in acute stroke?
Is recovery dependent on dosage of stimulation?

HYPOTHESIS:
Electrical stimulation produces better motor recovery than conventional physiotherapy in acute stroke.
Motor recovery in acute stroke is related to dose of stimulation.
1) 20 minutes of ES produces similar recoveryas compared to 30 minutes of ES.
2)45 minutes of ES produces similarmotor recovery as compared to 60 minutes of ES.
NULL HYPOTHESIS:
Electrical stimulation does not produce motor recovery in acute stroke as compared to conventional therapy and is not related to the dose of stimulation.
1)20 minutes of ES would not show similar results as compared to 30 minutes.
2)45 minutes of ES would not show similar results as compared to 60 minutes.
OPERATIONAL DEFINITION

• Neuromuscular electrical stimulation (NMES) is the application of electrical stimulation to produce skeletal muscular contractions as a result of the percutaneous stimulation of peripheral nerves12.
• Routine physiotherapy- Positioning, active assisted movements, appropriate splinting and stretching.

6.2 OBJECTIVES OF THE STUDY:
1) To find the effect of electrical stimulation in acute stroke subjects compared to conventional physiotherapy.
2) To find correlation between duration of electrical stimulationand functional recovery.
3)To calculate minimal effective dose from 20 minutes and 45minutes of electrical stimulation in stroke subjects as compared to 30 minutes and 60 minutes duration.
4)To link motor recovery to duration in Acute stroke.

6.3 REVIEW OF LITERATURE:
The impact of stroke worldwide:As per a study by Wolfe CD the socio-economic impact of stroke is considerable world-wide. It is estimated that there are 4.5 million deaths a year from stroke in the world and over 9 million stroke survivors. One year after a stroke, 65% of survivors are functionally independent, stroke comprising the major cause of adult disability13.
Impairment following stroke:Another study conducted by Dundas R et al determined that impairments of motor deficit, urinary incontinence, dysphagia, impaired consciousness, cognitive dysfunction, and cortical deficits were highly prevalent in a complete stroke population in the acute stage and independently predicted poor outcome at 3months14.
Natural progression of motor recovery following stroke:As per the study by Nakayama H et al, the best possible upper extremityfunction was achieved by 80% of the patients within 3 weeks after stroke onset and in patients with mild UE paresis, within 3 and 6 weeks, respectively15.
Treatment modalities in stroke:As per the systematic review conducted by Barecca S et al which indicated that sensorimotor training, electrical stimulation alone, or combined with biofeedback; and engaging the client in repetitive, tasks is effective in reducing motor impairment after stroke. Furthermore NMES could effectively reduce or prevent pain in the paretic upper limb16.
As per a study byKwakkel G et al to assess the effect of augmented exercise therapy after stroke states that augmented exercise therapy has a small but favourable effect on ADL, particularly if therapy is augmented 16 hours within the first 6 months after stroke. This supports the supplementation of rehabilitation by use of ES17.
Electrical stimulation in treatment of stroke: Somatosensory stimulation applied to a paretic limb can benefit functionality in patients with stroke, showing that in combination with training protocols NMES may enhancethe benefit of customary interventions and possibly motor learning as proved in a study performed by Carolyn W et al18.
As per a study by Kimberly TJ et aluse of NMESto facilitate hand opening in strokesubjects obtained improvement of in recovery of handfunction.The index ofcorticalintensityusing functional MRIincreased significantly in the ipsilateralsomato-sensory cortex. These findings suggest that NMES has an important role in stimulatingcorticalsensory areas allowing for improved motor function5.
Role of NMES as an accepted modality inducing motor recovery of the Upper extremity in stroke:
Chae J et al demonstrated that NMES in hemiplegiafacilitates upper and lower limb motor relearning. There is growing evidence that NMES, facilitates task-specific strategiesandpost-stroke pain6.
In a study performed by Lin Z et al significant improvements were found in experimental group receiving ES in addition to standard treatment and alsoin control group receiving conventional physiotherapyafter the 3rd week of treatment. These improvementspersisted 1 month after treatment had been discontinued. At 3 and 6 months after treatment was discontinued the average scores in the neuromuscularelectrical stimulationgroup were significantly better than those in the control group showing carry over effects of NMES19.
As per a study by Powell J et Al cyclic ES of the wrist extensors enhances motor recovery and reduces disability howeverthey could not state whether reduction in UE disability would be maintained after treatment is stopped9.
Studies have shown stroke survivors treated with NMES gained greater UE motor recovery than control subjects. However, these gains in the motor function did not translate into significant improvement in their ADL’s as stated by ChaeJ et Al5.
As per a study by Lankhorst G J et al stimulation of extensors of the hand versusalternate stimulation of flexors and extensors, the differences in functional gain and success rate were not statistically significant9.
Relationship of stimulation parameters to motor recovery:As per the systematic review performed by de Kroon J R et al consisting of 22 clinical trials, investigating relations of various Parameters of ES to motor recovery they concluded that no relationship exists between stimulus parametersand clinical outcome. They stated however that triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating UE motor recovery following stroke7.
A study stimulating wrist extensors using duration parameters 60 minutes, 30 minutes versus control group has shown that by allocation of dose as high (60 minutes) and low (30 minutes) results did not demonstrate a significant difference between the 2 NMES groups. Increasing the stimulation dose of NMES did not lead to greater improvement as stated by Shu-Shyuan Hsu et al11.

Outcome measures:
Recovery of hand function and grasp will be measured using ARAT which is an observational test used to determine UE function and designed to assess recovery in the UE following cortical damage20.
As per a study by Chiang FM the score of the ARAT was closely correlated with that of the upper extremity part of the motor assessment scale (Pearson r = 0.96) Hence the results of this study support the value of the ARAT for measuring recovery of arm-hand function in stroke patients21.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia22.
As per a study by Woodbury M L et al the FMA-UE (Fugl-Meyer Assessment Upper extremity) has strong psychometric properties.The items in the UE component testing resting-state reflexes maythreaten the assessment’s dimensionality, with their removalthe assessment is a unidimensional measure of volitional movement23.
The Barthel Index (BI) is a popularly used tests for evaluation of functional status24. When assessing patients who had a stroke, the test-retest reliability was found to be 0.989, and inter-rater reliability was 0.994.The validity of the Barthel Index used for patients with stroke was shown to be high.Cronbach’s alpha was 0.935 and Spearman’s correlation coefficient was -0.912 (compared to other ADL scales) 25.
MATERIALS AND METHODS:
7.1 SOURCE OF DATA :-
Stroke patients from Father Muller Medical Collegehospital, Mangalore admitted referred to Physiotherapy.
7.2 METHOD OF COLLECTION OF DATA :
STUDY DESIGN:-
Randomized Controlled Study.

SAMPLE PROCEDURE AND SAMPLE SIZE:-
Purposive sampling technique will be used.
Sample size, Method and Outcome Measures-
30 stroke patientsadmitted in FMMCH presenting with clinical and radiological signs of strokewill be considered for the study after getting informed consent. Demographic data will be collected from subjects meeting the inclusion criteriafollowed by the evaluation withoutcome measures which includesFugl-Meyer scale upper limb component, Barthel index and ARAT.Subjectswill be randomly assigned into 3 groups of 10 using each as follows and will receive treatment as mentioned. Irrespective of the group, they will receive conventional Physiotherapy.
Group A: Experimental group 1, receiving 20 minutes of ES with 33 Hz frequency, 0-60 mA amplitude and 100-300 µs pulse duration.
Group B : Experimental group 2, receiving 45 minutes of ES with 33 Hz Frequency, 0-60 mA amplitude and 100-300 µs pulse duration.
Group C: Control group receiving conventional physiotherapy.
Experimental group will receive ES once daily till discharge.
Instrumentation and parameters : BLT series 5000, 115V/230 V.
Current: symmetric alternating square wave.
Waveform: square waveform
Frequency: 33 Hz,
Amplitude: 0-60
Pulse duration: 100-300 µsec
On/off Ratio: 1:5
Electrode size: carbon impregnated rubber electrodes, length: 6.9 cms; width: 5cms.
Muscle group stimulated: Wrist extensors.
Electrode Placement: Monopolar typewith active electrode placed at the midpoint between lateral epicondyle and ulnarstyloid process and the reference electrode placed distally on the forearm above ulnarstyloid process.
On 7th day of intervention outcome measures will be scored from all the groups.

FLOWCHART
Stroke patients admitted in FMMCH from November 2011 to December 2011

Meeting inclusion criteria

Demographic data, Base line measurements:Upper limb component of Fugl-Meyer scale, ARAT, Barthel Index.

Randomization


Group A Group B Group C
Experimental group Experimental Group Conventional physiotherapy receiving ES. receiving ES.


20 minutes of ES 45 minutes of ES
Frequency: 33 Hz Frequency: 33 Hz
plus conventional therapy plus conventional therapy

Outcome Measures (Upper limb component of Fugl-Meyer scale, ARAT
& Barthel Index)

OUTCOME MEASURES:
Motor recovery of upper extremity will be measured using upper limb component of Fugl-Meyer Scale.
Functional recovery will be measured using Barthel Index
Recovery hand function will be measured using Action arm research test (ARAT).
INCLUSION CRITERIA:

• Recent stroke (< 10 days)
• Male and female patients 40-55 years of age
• First stroke
• MCA involvement
• Ischaemic stroke
• Glasgow coma scale score > 13
• Unilateral stroke
• Minimal scoring on Fugl-Meyer scale upper limb component: score less than 44.

EXCLUSION CRITERIA :

• Brainstem pathology
• Sensory aphasia
• Cognitive impairments
• Unstable vital parameters,
• Cardiac pacemakers,
• Deteriorating stroke,
• Hemorrhagic stroke.

STATISTICAL ANALYSIS :
Data will be analyzed using mean, standard deviation and ANOVA (analysis of variance).
7.3 Does the study require any investigation or intervention to be conducted on patients or animals?
Yes.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes, attached herewith

8. / LIST OF REFERENCES :
1. Powell J, Pandyan D., Granat M., Cameron M. and Stott D.J.Electrical Stimulation of Wrist Extensors in Post strokeHemiplegia. Stroke1999; 30: 1384–1389.
2. Nudo RJ, Wise BM, SiFuentes F, Milliken GW Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science 1996; 272: 1791–1794.
3. Wyller TB, Sveen U, Sødring KM, Pettersen AM, Bautz-Holter E.Subjective well-being one year after stroke.ClinRehabil.1997;11(2):139-45
4.Chae J, Yu D.A critical review of neuromuscular electrical stimulation for treatment of motor dysfunction in hemiplegia. Assist Technol.2000;12(1):33-49.
5.Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JRElectrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res.2004 ;154(4):450-60.
6. ChaeJ. ,Bethoux F, Bohinc T, Dobos L, PT; Davis T, Friedl A, Neuromuscular Stimulation for Upper Extremity Motor and Functional Recovery in Acute Hemiplegia. Stroke 1998; 29: 975–979.

7.de Kroon K R , Jzerman, M J, Chae J, Lankhorst G J and Zilvold G.Relation Between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke.JRehabil Med 2005; 37: 65–74.

8. Baker LL, Yeh C, Wilson D, Waters RL Electrical stimulation ofwrist and fingers for hemiplegic patients, Phys Ther.1979 ;59(12):1495-9.
9. de Kroon JR, IJzerman MJ, Lankhorst GJ, Zilvold G. Electrical stimulation of the upper extremity in stroke stimulation of the extensors of the hand versus alternate stimulation of flexors and extensors. Am J Phys Med Rehabil 2004; 83: 592–600.
10. Hendricks HT, IJzerman MJ, de Kroon JR, Groen FA,Zilvold G. Functional electrical stimulation by means of the “Ness handmasterorthosis” in chronic stroke patients. An explorative study, ClinRehabil.2001 ;15(2):217-20
11. Shu-Shyuan Hsu, Ming-Hsia Hu, Yen-Ho Wang, Ping-Keung Yip, Jan-Wei Chiu and Ching-Lin Hsieh Dose-Response Relation Between Neuromuscular Electrical Stimulation and Upper-Extremity Function in Patients With Stroke. Stroke 2010, 41:821-824.
12. Sartorio A, Jubeau M, Agosti F, De Col A, Marazzi N, Lafortuna C L and Maffiuletti N A
GH responses to two consecutive bouts of neuromuscularelectrical stimulation in healthy adults. European Journal of Endocrinology (2008) 158 311–316.
13. Wolfe CD The impact of stroke. Br Med Bull.2000;56(2):275-86
14. Lawrence E.S , Coshall C, Dundas R, Stewart J, Anthony G. Rudd, Howard R and Wolfe C.D.AMultiethnic Population Estimates of the Prevalence of Acute Stroke Impairments and Disability in a Multiethnic Population, Stroke.2001 32(6):1279-84.

15.Nakayama H,Jørgensen HS,Raaschou HO,Olsen TSRecovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil 1994; 75: 394–398.

16. Barecca S, Wolf SL, Fasoli S, Bohannon R Treatment interventionsfor the paretic upper limb of stroke survivors. Neurorehab Neural Repair 2003; 17: 220–226.
17.Kwakkel G, van Peppen R,Wagenaar R C,Dauphinee S W, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, PhD; Wellwood I, MPhil, Langhorne P Effects of Augmented Exercise Therapy Time After Stroke: A Meta-Analysisstrokejournals at VA MED CTR BOISE 2011.
18. Carolyn W. Wu, PhD, Hyae-Jung Seo, MD, Leonardo G. Cohen, MDInfluence of Electric Somatosensory Stimulation on Paretic-Hand Function in Chronic Stroke, Arch Phys Med Rehabil.2006;87(3):351-7.
19.Lin Z,Yan TLong-term effectiveness of neuromuscularelectrical stimulationfor promoting motor recovery of the upper extremity after stroke, J Rehabil Med.2011 43(6):506-10.
20.McDonnell MAction Research Arm Test.Australian Journal of Physiotherapy 2008 Vol. 54.
21. Hsieh CL,Hsueh IP,Chiang FM,Lin PHInter-rater reliability and validity of the action research arm test in stroke patients,.Age Ageing.1998 ;27(2):107-13
22. Gladstone DJ, Danells CJ, Black SE The Fugl-Meyer assessment of motor recovery after stroke: A critical review of its measurement properties.Neurorehabil Neural Repair.2002;16(3):232-40.
23. Woodbury M L, Velozo C, Richards L.G, Duncan P.W, Studenski S, Sue-Min Lai Dimensionality and Construct Validity of the Fugl-Meyer Assessment of the Upper Extremity. Arch Phys Med Rehabil.2007; 88(6):715-23.
24. Mahoney FI, BarthelDW.Functional evaluation: the Barthel Index. Md State Med J, Md State Med J.1965; 14:61-5.
25. Oveisgharan, S, et alBarthel Index in a Middle-East country: translation, validity and reliability. Cerebrovascular Disease,Cerebrovasc Dis.2006;22(5-6):350-4.
9. / SIGNATURE OF THE
CANDIDATE
10. / REMARKS OF THE GUIDE
11. / NAME AND DESIGNATION OF
11.1 GUIDE
11.2 SIGNATURE
11.3 HEAD OF THE DEPARTMENT
11.4 SIGNATURE / MR. JIDESH V.V
ASSISTANT PROFESSOR
DEPT OF PHYSIOTHERAPY
MR.NARASIMMAN SWAMINATHAN
PROFESSOR
DEPT OF PHYSIOTHERAPY
12. / 12.1 REMARKS OF THE
CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
ANNEXURE III
CONSENT FORM
Ms. Megha V. Kamat Date-
MASTER OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS (MPT-NPD)
Father Muller Medical College,
Mangalore-575002
You are requested to be a part of this research study, which is a part of the curriculum for the course of M.P.T. run by the Rajiv Gandhi University of Health Science. The purpose of the study is to test the effect of electrical stimulation in acute and to find the relationship of motor recovery to duration of stimulation in post-stroke patients admitted in FMMCH.
On entering in this study you will be tested for Upper limb component of Fugl-Meyer assessment scale, Action research arm test and Barthel index at referral and 7 days later.These procedures will not cause any harm to you.
We will clarify any of your queries regarding the study. Your Identity will remain confidential. You are free to leave this study at any time.
You are requested to sign this consent form.
I, ______voluntarily agree to participate in this research study. I am fully aware of the procedure that will be carried out.
Signature of the patient.
ANNEXURE IV
PERFORMA
Name:
Age: Gender: M/ F
Address :
Contact No.:
Type of stroke:
Side of stroke:
Date of Admission: Date of Discharge:
No. of days in hospital stay:
Outcome Measures Scores:
Sr No. / Outcome Measures / At referral to physiotherapy / 7days later
Upper Limb component of
Fugl-Meyer assessment scale
Action research arm test
Barthel index