Bangalore
Annexure II
1. / Name of the candidate and address (in block letters) / POONAM MAHESHWARI
Dr. M. V. SHETTY COLLEGE OF PHYSIOTHERAPY,
VIDYA NAGAR, KULOOR,
MANGALORE-575013
2. / Name of the Institution / Dr. M. V. SHETTY COLLEGE OF PHYSIOTHERAPY
3. / Course of study and subject / MASTER OF PHYSIOTHERAPY (MPT) IN NEUROLOGY AND PSYCHOSOMATIC DISORDER
4. / Date of admission / 5 JULY 2012
5. / Title of the Topic / EFFECT OF OTAGO EXERCISE PROGRAMME ON BALANCE IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
6. / Brief Resume of the Intended Work
6.1) Introduction and Need of the Study:
Diabetes mellitus is a difficult disease with potentially very painful prognosis. The relentless inevitability of diabetes leads to serious neurologic dysfunction over the years1. The World Health Organization has described type 2 diabetes as an international epidemic2. Diabetic neuropathy is a late complication of diabetes mellitus resulting from decreased blood flow and high blood sugar levels. Diabetic neuropathies are common among patients with diabetes, affecting 66% of patients with insulin-dependent diabetes mellitus and 59% of patients with noninsulin dependent diabetes mellitus3.
Type 2 diabetes mellitus and its common complication, peripheral neuropathy, affects a large population4,5. Peripheral neuropathy leads to sensory and motor deficits, which often result in mobility-related dysfunction, alterations in gait characteristics6,7 and balance impairment8,9. One of the major complications associated with diabetic neuropathy is bilateral loss of somatosensory information in the hands and feet. Such a somatosensory deficit in the feet compromises functional
postural stability of patients with diabetic neuropathy and might place them at a higher risk of falling
when performing more challenging daily tasks. It was also shown that diabetic subjects with peripheral neuropathy have demonstrated a significant loss of ankle movement perception, have larger ranges of postural sway, and are more likely to use hip control balance strategy. As a result of the percentage of individuals diagnosed with diabetes who develop polyneuropathy after 20 years reaches 50%, the number of balance studies involving diabetic patients is growing10.
The fact that balance disorders can occur from a wide range of causes explains. The earliest scientific studies of human standing balance was conducted by Romberg in 1853, who observed the evaluation of balance disorders has an important role for a number of reasons. Furman in 1994 conducted a study stating Balance assessment tests should attempt to stimulate dynamic conditions in order to stress the postural control system fully and reveal the presence of a balance disorder (Balance disorders are more prevalent in elderly subjects, with disorders occurring due to the ageing process or diseases of the CNS, sensory system and occasionally the vestibular system). Due to the complexity of the postural control system, balance can be evaluated at both a functional and a physiological level. The functional level can be more directly assessed by functional performance tests of reach and mobility. The physiological level includes measuring the contribution of sensory, motor and effector components11.
Individuals with peripheral neuropathy show postural instability with a larger centre of pressure displacement12 higher sway area13 and greater instability when standing still with eyes closed 14. Postural instability was further found to be significantly associated with sensory neuropathy15. In addition to these gait and balance impairments, diabetic patients are known to suffer from increased risk of injurious falls 16. Fall-related injuries are often assumed to trigger a vicious circle because of their potentially detrimental influence on the physical activity levels of affected patients. Public Health guidelines for diabetes management recommend that patients perform at least 30 min of physical activity a day six times a week, requiring adequate gait security and balance. However, little is known about treatment strategies that could improve patients’ gait and balance, thereby also reducing the risk of falls. Although there is evidence that an exercise regimen improves clinical measures of balance in patients with peripheral neuropathy17.
The Otago exercise programme (OEP) is a falls prevention programme developed in New Zealand to target the modifiable falls risk factors of lower limb weakness and impaired balance.18 The Otago
exercise programme (OEP) is a strength and balance retraining programme designed to prevent falls
in people living in the community. It is effective in reducing the number of falls and fall-related
injuries. The OEP was defined as a tailored, strength and balance retraining programme, where resistance to lower limb muscles was provided via ankle cuff weights and the programme was carried out at least three times per week. The programme needed to include the following features:
• individually tailored
• increased in difficulty (increasing resistance, repetitions, the difficulty of balance exercises and/or the duration of the walking component)
• a walking programme to complement the strength and balance programme.19
Need of the study:
Diabetic peripheral neuropathy is common complication of diabetes mellitus type 2 and studies shows that patients with diabetic peripheral neuropathy experiences balance problems and fall related injuries. Otago is a strength and balance retraining exercises improve balance and helps in prevention of fall and fall related injuries. Hence arises the need to see the effect of otago exercise programme on balance in patients with diabetic peripheral neuropathy.
Research Question:
Will Otago exercise programme bring improvement on balance in patients with diabetic peripheral neuropathy?
Hypothesis:
Alternate hypothesis: The Otago exercise programme will be effective on balance in patients with diabetic peripheral neuropathy.
Null hypothesis: The Otago exercise programme will not be effective on balance in patients with diabetic peripheral neuropathy.
6.2) REVIEW OF LITERATURE:
Dyck PJ,Kratz KM, et al conducted a study “the prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study” and concluded that Diabetic neuropathy is a late complication of Diabetes mellitus resulting from decreased blood flow and high blood sugar level4.
L. Allet, S. Armand,et al in their study on “the gait and balance of patients with diabetes can be improved: a randomised controlled trial” concluded that Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patient20.
Laurence Z. Rubenstein conducted a study on “Falls in older people: epidemiology, risk factors and strategies for prevention” concluded that Considerable evidence now documents that the most effective (and cost-effective) fall reduction programmes have involved systematic fall risk assessment and targeted interventions, exercise programmes and environmental-inspection and hazard-reduction programmes21.
Herwaldt and Pottinger, et al did a study on “Preventing falls in the elderly” concluded that Balance exercise programs can be effective in improving gait and balance, as well as reducing falls and fall-related injuries22.
Hoda Salsabili, Farid Bahrpeyma,et al did a study on “Dynamic stability training improves standing balance control in neuropathic patients with type 2 diabetes” and concluded that training that compensates for disordered balance indicated by subclinical constraints with respect to the guidance effect of external visual feedback improves standing postural control in patients with type 2 DN23.
Boucher P, Teasdale N, et al conducted a study on “Postural stability in diabetic polyneuropathy” and concluded that the postural stability of neuropathic patients is impaired and may put them at higher risk of falling when performing more challenging daily tasks24.
Mohammad Akbari, Hassan Jafari, et al in their study on “Do diabetic neuropathy patients benefit from balance training?” concluded that People with diabetic neuropathy have balance disorders even with open eyes, making them vulnerable to falls25.
Gillespie LD,Robertson MC et al did a study on “Interventions for preventing falls in older people living in the community” and concluded that Group and home-based exercise programmes, and home safety interventions reduce rate of falls and risk of falling26.
Maurer MS,Burcham J,Cheng H did a study on “Diabetes mellitus is associated with an increased risk of falls in elderly residents of a long-term care facility” and concluded that diabetes mellitus is an independent fall risk factor among elderly nursing home residents27.
Lindop, F.A.,et al conducted a study on “Evaluation of an Otago-based exercise group for people with Parkinson's disease” and concluded that an 8 week programme of Otago-based exercises improved balance as assessed by the Berg Balance Scale. The biggest improvement in those at greatest risk of falling is encouraging28.
7. / Melina M.Gardner, David M.Buchner, et al in their study on “Practical implementation of an exercise based fall prevention programme” concluded that Leg muscle weakness and poor balance are so common, that specific strength and balance exercises need to be part of any fall prevention programme29.
Keith D Hill, Dina LoGiudice et al conducted a study on “Effectiveness of balance training exercise in people with mild to moderate severity Alzheimer's disease: protocol for a randomised Trial” and concluded that otago exersice programme support a case for balance screening and the provision of a balance training exercise programme as a routine component of early management for people diagnosed with Alzheimer's disease30.
Suzanne M Lynch, Patricia Leahy et al did a study on “Reliability of Measurements Obtained With a Modified Functional Reach Test in Subjects With Spinal Cord Injury” and concluded that Test retest reliability was high with modification of the Functional Reach Test with a single rater. The modified Functional Reach Test appears to provide reliable measurements of sitting balance in non standing persons with spinal cord injuries31.
Schoppen T, Boonstra A, et al conducted a study on “The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation” and concluded that The Timed "up and go" test is a reliable instrument with adequate concurrent validity to measure the physical mobility of patients with an amputation of the lower extremity32.
Katz-Leurer M,Fisher I, et al in their study on “Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke” and concluded that The Modified Functional Reach Test in all directions on both occasions exhibited high reliability (intra-class correlation coefficient range, 0.90 - 0.97). The Modified Functional Reach Test while sitting can be reliably measured and may serve as a useful outcome measure in individuals with stroke 2 - 8 weeks post-event33.
6.3) OBJECTIVES OF STUDY:To determine the effectiveness of Otago exercise programme on balance in diabetic peripheral neuropathy patient.
MATERIALS AND METHODS:
7.1) STUDY DESIGN:
Pre and post without control design
7.2) SOURCE OF DATA:
Patients with medically diagnosed diabetic peripheral neuropathy in Govt. Wenlock Hospital and Dr.
M.V.Shetty Trust Hospital, Mangalore.
7.2 (I) DEFINITION OF THE STUDY SUBJECTS:
Patients with Diabetic Peripheral Neuropathy in the age group of 30 to 75 years.
7.2 (II) INCLUSION AND EXCLUSION CRITERIA:
Inclusion criteria
· Informed consent
· Age group 30-75 years34
· Male and Female
· Medically diagnosed type 2 Diabetic Peripheral Neuropathy
· Patient without medical contraindication for engaging in physical activity
· Patient can walk minimum 500m
· No ankle injuries in the six month before application of study
Exclusion criteria
· Concomitant foot ulcer
· Orthopeadic or surgical problem affected balance
· Non diabetic neuropathy
· Other neurological pathologies(other than peripheral neuropathy)
· Inability to walk minimum 500m
7.2 (III) STUDY SAMPLE DESIGN, METHOD, SIZE:
Sample design and method:
Purposive sampling technique.
Sample size:
Around 60 patients will be selected.
7.2 (IV) FOLLOW UP:
Not applicable.
7.2 (V) PARAMETERS USED FOR COMPARISON AND STATISTICAL TEST:
Collective data will be analyzed by standard deviation paired ‘t’ test.
7.2 (VI) DURATION OF STUDY:
Duration of the study will be 12 months.
7.2 (VII) METHODOLOGY:
Diagnosed Diabetic Peripheral Neuropathy patients referred by physician and neurologist will be initially assessed in the physiotherapy department for inclusion and exclusion criteria. Subjects aged 30 to 75 years diagnosed for Diabetic Peripheral Neuropathy will be randomly allocated in two groups. Balance assessment measure will be taken by Timed up and go test and Modified functional reach test. Participants underwent training in groups. Teaching occurred for 3 days in a week for 8 weeks, each session lasted 75 minutes.
Otago exercise programme consisted of the teaching of a series of strength and balance retraining exercises with ankle cuff weight and 30 min. walking twice a week. Patients would be demonstrated the technique and asked to follow. Repetitive trails would be given to the subjects until they got well with the technique. After 8 weeks the subjects would be again assessed for balance by Timed up and go test and Modified functional reach test.
7.3) Does the study require any investigations to be conducted on patients or other human or animal if so please describe briefly?
Yes. Timed up and go test, Modified functional reach test.
7.4) Has ethical clearance been obtained from your institution in case of 7.3.
Yes
8. / LIST OF REFERENCES :
1) B. Eliot Cole Consensus Guidelines: Assesment, Diagnosis, and Treatment of Diabetic Peripheral Neuropathic Pain. American Society of Pain Educators April 2006 Volume 81 Number 4
2) Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 27:1047-1053, 2004.
3) Sadosky, A., McDermott, A. M., Brandenburg, N. A. and Strauss, M. (2008), A Review of the Epidemiology of Painful Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Less Commonly Studied Neuropathic Pain Conditions. Pain Practice, 8: 45–56.
4) Dyck PJ, Kratz KM, Karnes JL, et al. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993;43:817–824.
5) Ziegler D, Gries FA, Spuler M, Lessmann F. The epidemiology of diabetic neuropathy. Diabetic Cardiovascular Autonomic Neuropathy Multicenter Study Group. J Diabetes Its Complicat. 1992;6:49–57.
6) Allet L, Armand S, Bie RA, et al. Gait alterations of diabetic patients while walking on different surfaces. Gait Posture. 2009;29:488–493.
7) Allet L, Armand S, Golay A, Monnin D, Bie R, Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008;24:173–191.
8) Goldberg A, Russell JW, Alexander NB. Standing balance and trunk position sense in impaired glucose tolerance (IGT)-related peripheral neuropathy. J Neurol Sci. 2008;270:165–171.