Master of Physiotherapy in Neurological and Psychosomatic Disorders (Mpt-Npd)

RESEARCH PROPOSAL

EFFECT OF VERY EARLY MOBILISATION ON THE FUNCTIONAL OUTCOME AND RELATED COMPLICATIONS FOLLOWING STROKE-A RANDOMISED CONTROLLED TRIAL

MASTER OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS (MPT-NPD)

Ms. VANI GOLWARA

DEPT OF PHYSIOTHERAPY FATHER MULLER MEDICAL COLLEGE MANGALORE-575002

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

NAME OF THE CANDIDATE Ms. VANI GOLWARA

1 AND DEPARTMENT OF PHYSIOTHERAPY

ADDRESS FATHER MULLER MEDICAL COLLEGE

KANKANADY

MANGALORE – 575 002

NAME OF THE INSTITUTION FATHER MULLER MEDICAL COLLEGE, 2 MANGALORE

COURSE OF STUDY AND SUBJECT MASTER OF PHYSIOTHERAPY 3 IN NEUROLOGICAL AND

PSYCHOSOMATIC DISORDERS

(MPT-NPD) 4 DATE OF ADMISSION TO COURSE 31-05-09

5. TITLE OF THE TOPIC:

EFFECT OF VERY EARLY MOBILISATION ON THE FUNCTIONAL OUTCOME AND RELATED COMPLICATIONS FOLLOWING STROKE-A RANDOMISED CONTROLLED TRIAL

BRIEF RESUME OF THE INTENDED WORK: 6.1 Need of the study:

Stroke is a major health problem in developing countries. In the next 30 years the burden of stroke will grow most in developing countries rather than in developed countries.1 It ranks second after ischemic heart disease as a cause of DALY (disability adjusted life in years) in high income countries and a cause of death world wide2. Because of the enormity of the burden of stroke globally, there is a real need to develop strategies to reduce its impact. Stroke patients are at very high risk of developing complications, with an estimated 85% experiencing complications like infections, pressure sores, contractures, deep vein thrombosis (DVT), pulmonary embolism and pain during their hospital stay3.Complications resulting from immobility may account upto 51% of deaths in first 30 days after ischemic stroke, with over 62% complications occurring in 1st week4. This emphasizes the need of mobilisation as early as possible. Early mobilisation is recommended in a number of clinical guidelines for acute stroke rehablitation5. But opinions vary widely about the timing of first out of bed activity after stroke. In Trondheim6 stroke unit, very early mobilisation (≤24 hour) is practiced for over 10 years. In their stroke unit, shorter time to start of mobilisation/training was found to be the most important factor associated with early discharge followed by stabilized diastolic blood pressure (BP). A study on stroke patients admitted within 24 hours of stroke onset found that majority (86%) of patients tolerated the early mobilisation (median 22 hours) & completed the protocol7. They were able to sit out of bed for 55 minutes on first day of stroke with arguably small & transient increase in BP and heart rate (HR) and positive effects on consciousness & oxygen saturation. In an animal study early exercise (<24 hours) was found to have better neurological function & reduced infarct volume8. A 3 phase research is performed on very early rehabilitation, with emphasis on mobilisation (< 24 hours) 9, 10. Phase I concluded that patients in Australia in acute phase were not mobilized often and an earlier start & higher dose of mobilization can be added as part of clinical trial. Phase II they found their protocol of very early mobilization to be safe & feasible.11. It has been proved that very early mobilisation may also reduce depressive symptoms in stroke patients at 7 days post stroke12. Stroke outcome in a rehabilitation setting is influenced by a number of factors. Phase III13, 14 of the study to determine both efficacy and cost effectiveness of their protocol is underway. So this study aims to determine the effect of very early mobilisation on the functional outcome and presence of complications in Stroke patients.

. Research question  Whether very early mobilisation improves the functional outcome and decreases related complications following stroke?

Hypothesis  Very early mobilisation significantly improves the functional outcome and decreases related complications following stroke.

Operational definition

Very early mobilisation

Patient brought to upright sitting within 17 to 24 hrs (Day 1) after stroke onset and to make the patient upright sit or stand within 24 to 48 hours (Day 2) after stroke onset.

Routine physiotherapy

Routine physiotherapy includes position change in the bed, chest physiotherapy, range of motion exercises, tone regulation and movement reeducation.

Complications related to Stroke

Pressure sores, Respiratory complications, Deep vein thrombosis (DVT), Mortality

6.2 Review of Literature Asia Pacific Consensus Forum on Stroke Management1. Consensus Statement 6. Developing Countries, Remote and Rural Issues states that two thirds of the world population lives in developing countries and Stroke is a major health problem in developing countries. In the next 30 years the burden of stroke will grow most in developing countries rather than in developed countries.

In their study ‘Treatment in a Combined Acute and Rehabilitation Stroke Unit Which Aspects Are Most Important?’ Indredavik, F. Bakke, S. A. Slørdahl, R. Rokseth and L. L. Håheim6, analyzed the factors that were able to measure and their association with the outcome, discharge to home within 6 weeks and concluded that time to start of mobilisation/training was the most important factor associated with discharge home, followed by stabilized diastolic BP.

In Early mobilisation after stroke: Review of literature, Karin Diserens , Patrick Michel, Julien Bogoussiavsky15(2006) highlighted recent advances in recommendation for mobilisation of acute stroke and early neurological rehabilitation. Also gave a standarised procedure for early mobilisation.

In ‘Inactive and Alone Physical Activity Within the First 14 Days of Acute Stroke Unit Care’ Julie Bernhardt, PhD; Helen Dewey, PhD; Amanda Thrift, PhD Geoffrey Donnan, MD9 proposed that One way that stroke units may improve outcome is by reducing complications of immobility through early mobilization; however, this intervention needs testing. The next step is to conduct a randomized controlled trial to evaluate the effect of increased levels of physical activity early after stroke compared with current standards of care.

In very early rehabilitation trial for stroke (avert) phase II, Julie bernhadt Helen dewey, Amanda thrift, Janice collier, Geoffrey donnan,M11 found very early mobilisation of patients within 24 hours of acute stroke safe and feasible. In the effect of very early mobilisation after stroke on psychological well-being, Toby B. Cumming, Janice Collier, , Amanda G. Thrift, and Julie Bernhardt12, proposed that the immobility common to patients after acute stroke has the potential to increase negative mood symptoms. They performed a randomized controlled trial to evaluated the effect of very early mobilisation after stroke on levels of depression, anxiety and irritability and concluded that VEM may reduce depressive symptoms in stroke patients at 7 day.

6.3 Objective of the study

 To study the effects of very early mobilisation following stroke on the functional outcome and related complications.  To study the effects of routine physiotherapy following stroke on functional outcome and related complications.  To compare the effects of very early mobilisation and routine physiotherapy on 7. functional outcome and related complications.

MATERIAL AND METHODS

7.1 Source of data All stroke patients admitted to Father Muller Medical College and Hospital (FMMCH) fulfilling inclusion criteria will be included in the study.

7.2 Method of data collection

Study design: Randomised controlled trial.

Study period: one year duration

Sample size: 40 stroke patients fulfilling the criteria will be enrolled in the study. The subjects will be divided into two groups, group I and group II on the basis of random numbers.

Inclusion Criteria  Stroke as defined by the World Health Organization, admitted within 24 hours of symptom onset.  Patients of age 40 to 60 years with a first time stroke,  React to verbal commands, need not to be fully alert.  Systolic blood pressure between 120 and 160 mm Hg.  Oxygen saturation of >92% (with or without supplementation),  Heart rate between 60 and 100 beats per minute  Stroke patients on routine medical management and supportive drugs( mannitol, ionotropes).  Blood glucose level between 81-360 mg/dl  Patients Hb > 7 gm/dl.  Platelet count > 20,000 cells/ mm³

Exclusion Criteria

 Premorbid Modified Rankin Scale (mRS) score >3  Deterioration within the first hour of admission.  Acute coronary syndrome, severe heart failure  Any musculoskeletal problem(like fracture) preventing mobilisation  Associated progressive Neurological condition.  Patients on mechanical ventilator.  Stroke patient having intracranial hemorrhage  Receiving tPA drugs.  Body temperature >38.5°C.

Proposal sent to Ethical committee and approval obtained.

Informed consent will be obtained from all subjects or their representatives.

Randomization Patient fulfilling inclusion criteria will be randomized into group I and group II based on random numbers taken from website www.randomisation .com.

Intervention Stroke Patients admitted to Father Muller Medical College within 24 hrs onsets of symptoms will be considered after obtaining informed consent. History and physical examination findings will be noted as per structured Performa .Those fulfilling the criteria will be randomly divided into Group I(Gr. I) & Group II (Gr. II). Patients randomized to Gr. I (experimental group) will receive very early mobilisation ie; they will be brought to upright sitting within 17 to 24 hrs (Day 1) after stroke onset and will be made upright sit or stand within 24 to 48 hours (Day 2) after stroke onset. Patients will be made to upright position (sitting or standing) twice per day, 6 days per week and will be continued till discharge. In addition they will receive routine physiotherapy, medical and nursing care. Physiologic monitoring of blood pressure, heart rate, oxygen saturation, and temperature before, during and after each mobilisation will be noted. Points for withdrawal

 If on attempt to mobilisation HR increases or decreases more than 20 to 30% of maximal HR for that age.  If systolic BP shows variability more than 20% from the baseline.  If SPO2 drops > 4% from the baseline.  If signs & symptoms of increasing respiratory distress occur.

Patients randomised to Gr II (control group) will receive routine physiotherapy, medical and nursing care. Here patients will be mobilised( upright sitting or standing) on day 3 of onset of stroke symptoms. Patients will be mobilised twice per day for 6 days in a week and it will be continued till discharge . Patient’s vitals will be monitored similar to Group I.And will be withdrawn from the study if fulfilling the withdrawing criteria.

Subjects

Randomised selection

Group I Group II Experimental group Control group

Day 1(17 to 24 hrs) Day 1 and day 2 only upright sitting and routine routine physiotherapy physiotherapy

Day 2 (24 to 48hrs) Box 3 upright sitting or Evidence to Day 3 routine standing and routine No withdraw physiotherapy continued physiotherapy patients* and mobilisation(upright continued sitting or standing) initiated

Yes Evidence to withdraw patients*

Box 4 withdraw patient patient

* If on attempt to mobilisation HR increases or decreases more than 20 to 30% of maximal HR for that age.

If systolic BP shows variability more than 20% from the baseline.

If SPO2 drops > 4% from the baseline.

If signs & symptoms of increasing respiratory distress occur. Functional outcome will be measured using Functional independence measure (FIM) (annexure II) in both the group at the time of admission and at seventh day of onset of stroke. Complications of the stroke patient at seven day post stroke onset will also be noted in both the groups.

Outcome measure

Functional independence measure scale

Scale for stroke related Complications

Statistical analysis:

Data will be analyzed using paired and unpaired t test and chi- square test.

8. 7.3Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly. Yes

7.4 Has ethical clearance been obtained from your institution in case of 7.3 Yes

LIST OF REFERENCES 1.Asia Pacific Consensus Forum on Stroke Management. Stroke. 1998;29:1730-1736.

2.Lopez AD, Mathers CD, Ezzati M, Janison DT, Murray CJ. Global and regional burden of disease and risk factors.2001: systematic analysis of population health data. Lancet 2006; 367: 1747-57.

3.Langhorne P, Stott D, Robertson L, Mac Donald J, Jones L, Medical complications after stroke: A muulti center study. Stroke 2000:1:122-9

4.Bamford J, Dennis M, Sandercock P, Burn J, Warlow C, .The frequency, causes, and timing of death within 0 days of a stroke: The Oxfordshire community stroke project. J Neurol Neurosurg Psychiatry 1990;53:824-9.

5.National stroke foundation. Clinical guidelines for acute stroke management. 2007. National stroke foundation, Melbourne Australia.

6.Indredavik, F. Bakke, S. A. Slørdahl, R. Rokseth and L. L. Håheim Treatment in a Combined Acute and Rehabilitation Stroke Unit : Which Aspects Are Most Important? Stroke 1999;30;917-923

7.Indredavik B, LOege A, Rohweder G, Lydersen S. Early mobilization of acute stroke patients is tolerated well, increases mean BP and oxygen saturation and improved consciousness .cerbrovascular disease 2007; 23:65

8.Yang Y, Wang R, Wang P. Early and late treadmill training after focal brain ischemia in rats. Neuosci Lett 2003; 39:91-4.

9.Bernhardt J, Dewey HM , Thrift AG, Donnan GA. Inactive and alone: Physical activity in first 14 days of acute stroke unit care .Stroke 2004;35:1005-9

10.Bernhardt J, Chitravas N, Lidarende Meslo, Thrift AG, Indredavik B .Not all stroke units are the same :A comparision of physical activity patterns in Melbourne, Australia and Trondhemin, Norway. Stroke 2008;9:2059-2065

11.Bernhardt J, Dewey HM , Thrift AG, Collier J, Donnan GA. A Very Early

Rehabilitation Trial for Stroke (AVERT) Phase II Safety and Feasibility.Stroke

2007. 12. Toby B. Cumming, Janice Collier, Amanda G. Thrift, and Julie Bernhardt, Effect of very early mobilization after stroke on psychological well-being J Rehabil Med 2008; 40: 609– 614

13.Bernhardt J, Dewey HM , Thrift AG, Collier J, Lindley R, Donnan GA. Lanset

Protocol review. A Very Early Rehabilitation trial(AVERT`) Phase III.

14. Bernhardt J, Dewey HM , Thrift AG, Collier J, Lindley R, Moodie M ,et al. A very

Early Rehabilitation trial( AVERT) .Int J Stroke2006

15. Karin Diserens, Patrick Michel, Julien Bogoussousky, Early mobilization after stroke – review of literature . 2006

9. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDE

NAME AND DESIGNATION OF MR. JIDESH V.V ASSIST.PROFESSOR 11.1 GUIDE DEPT OF PHYSIOTHERAPY

11.2 SIGNATURE

11.3 CO-GUIDE

11.4 SIGNATURE

MR.NARASIMMAN S. 11.5 HEAD OF THE DEPARTMENT ASSOC.PROFESSOR DEPT OF PHYSIOTHERAPY

11.6 SIGNATURE

12. 12.1 REMARK OF THE CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE ANNEXURE-III CONSENT FORM

I, ______hereby agree to provide my fullest consent and co operation I, ______hereby agree to provide my fullest consent and co operation of my relative (patient) named as a model for the dissertation work of Ms. Vani Golwara titled “Effect of very early mobilisation on the functional outcome and related complications following stroke-a randomised controlled trial”

A Study to evaluate the effectiveness of two types of physiotherapy techniques on stroke patients.

The possible benefits and risks of the study as well as the procedure and duration of the study have been explained to me. The questions and queries I have posed have been answered to my satisfaction and I am aware that my/my relatives identity will be kept confidential. I am also aware that I can discontinue the study at anytime I wish to do so.

Place: Date: Signature (Patient)

Relationship with the patient & signature of (Patient relative)

Signature (Physiotherapist) Proforma Name: Age/sex: H No/IP No: Telephone No: Address:

Date & time of stroke onset: Type of stroke: Site of lesion: Associated neurological condition: Cardiac status: MI yes/no ECG : arrhythmia yes/no Mechanical ventilation yes/no: Musculokeketal problems yes/no: Premorbid Modified Rankin Scale (mRS) score: Physical examination : HR: RR: BP: Temp: SPO2(FIO2): GCS: CNS:

Investigation: Hb: RBS/GRBS: Platelets: TLC: ECG: arrhythmia yes/no Chest x ray (for diagnosis of pneumonia): CT scan/MRI if any: Group to which patients belongs: Time of mobilization given from stroke onset: Time when made patients upright from stroke onset:

Monitoring in mobilization

Vital signs Before mobilization After mobilization HR RR BP SPO2 Temp

Functional independence measure

Day 1 of stroke onset Day 7of stroke onset FIM score Complications:

Day 7of stroke onset Pressures sores DVT Respiratory complications

Mortality Reason: Time form onset of stroke

ANNEXURE-VII STROKE RELATED COMPLICATIONS

Pressure sore grading system

Grade I Discoloration of intact skin, including non blancheable erythema, blue/purple and black discoloration Grade II Partial thickness skin loss or damage involving epidermis and or dermis Grade III Full thickness skin loss involving damage or necrosis of subcutaneous tissue; but not through the underlying fascia and extending to the underlying structures Grade IV Full thickness skin loss with extensive destruction, and tissue necrosis extending to the underlying bone, tendon or joint capsule

Deep vein thrombosis Clinical Pain , tenderness, leg swelling. Non specific- warmth, erythema , palpable cord Investigation Venous duplex ultrasound Diagnostic criteria – venous duplex ultrasound

Respiratory complications Clinical criteria fever greater than 38°C, leukocytosis or leucopenia and purulent secretions Radiological New or progressive radiological infiltrates criteria Diagnostic criteria- radiological criteria plus at least two of three clinical features