RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION
1. / Name of the Candidate And
Address
(in block letters): / SHREYA. B. UPPIN
H.NO- 3535, RISALDAR LANE
BELGAUM - 590002
KARNATAKA
2. / Name of the Institute : / LAXMI MEMORIAL COLLEGE OF
PHYSIOTHERAPY, MANGALORE.
3. / Course of study and subject : / MASTERS OF PHYSIOTHERAPY (MPT)
2 YEARS DEGREE COURSE
PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS
4. / Date of Admission to Course : / 25 MAY 2010
5. / Title of the topic: /

“A STUDY TO FIND OUT THE EFFECTIVENESS OF

SENSORY RE-EDUCATION TO IMPROVE

BALANCE IN DIABETIC NEUROPATHY.”

6. / Brief Resume of the Intended Work:
6.1  NEED FOR THE STUDY
Diabetic neuropathy is a family of nerve disorders that occurs has a common complication of diabetes in which nerves are damaged has a result of high blood sugar ( hyperglycemia)1
India has a high prevalence of diabetes mellitus and the numbers are increasing at an alarming rate. In India alone, diabetes is increased from 40.6 million in 2006 to 79.4 million by 2030.2
Overall, 19.1% of the patient had evidence of neuropathy in south Indian population. The prevalence of neuropathy increased with increased in age and duration of diabetes.3
On average, symptoms begin 10 to 20 years after the diabetes diagnosis. Approximately 50% of people with diabetes will eventually develop nerve damage.1
Diabetes can increase accidents through poor balance issues due to numbness in the toes and feet. Reduced balance is affected by decreased vibration sensitivity which triggers imbalance problems and cause injurious accident.
Sensory component of peripheral neuropathy causes gradual loss of sensitivity to pain , perception to plantar pressure temperature and proproiception and can lead to postural instability.4
Balance training is utilization and integration of appropriate sensory systems. Normally three sensory source of inputs are utilized to maintain balance: somatosensory inputs ,visual inputs and vestibular inputs.5
Balance is controlled on the basis of afferent information from somatosensory input, visual and vestibular system. The first two system are often affected in presence of diabetic neuropathy.6 7 8
There somatosensory system appears to be biggest contributor of feedback for balance. This sensory system is composed of several different muscles, joint and cutaneous receptors. The information from these receptors is integrated in the CNS to produce a sensation of joint position and movement. Conversely the current literature attributes instability in diabetic neuropathy primarily due to loss of plantar cutaneous sensation. 8 9 10 11
Patient with diabetic neuropathy have decreased proprioceptive input that normally plays a role in adjusting irregularities in movement and maintaining balance.12
In this study, somatosensory input is used to improve the balance in diabetic neuropathy.
Semmes-Weinstein Monofilament is used to identify the threshold for sensory perception.13
Balance is assessed by using berg balance scale.
This study will help us to find out the impact of sensory re-education on balance.
The background of the dynamics of balance and the deficits in these areas among ambulatory diabetic, it is postulated that the balance training in ambulatory diabetic may be a useful exercise and may result in better out comes and improved function.14
Study by Anne Cook, Fay Horak on assessing the Sensory Interaction on Balance which says that standing, walking, swaying and functional movements on foam may be practiced by patients as a therapeutic treatment approach to improve flexible use of all senses for postural control. They also say that the preferred sensory input for the control of balance is somatosensory information from the feet in contact with support surface.14
Balance is common problem in diabetic neuropathy. It is seen that balance training with altered sensory input is better compared than without altered sensory Input. So this study is directed towards giving balance training with sensory re-education for improving balance and quality of life in diabetic neuropathy.
HYPOTHESES
NULL HYPOTHESIS (HO): There is no significant effect of sensory re-education to improve balance in diabetic neuropathy.
ALTERNATE HYPOTHESIS (H1): There can be significant effect of sensory re-education to improve in diabetic neuropathy.
6.2  REVIEW OF LITERATURE
Tanja oud and Anita Beelen et al studied the effectiveness of sensory re-education to improve hand function in peripheral nerve injuries. This study statically significantly showed improvement in hand function.15
Elizabeth A. lynch, Bappsc, Susan et al studied the effectiveness of sensory re-education on postural control and gait in acute stroke.16
Allet L, Armand S, de Bie R A et al studied gait and balance of patient with diabetes can be improved: a randomized control trial. In this study conclusion showed that specific balance exercise can improve balance in diabetic patient.17
Kelly P Westlake and Elsie G Culham studied to investigate the effect of sensory specific balance training on propriception. The result of this study support enhanced postural responses to proprioceptive integration following sensory specific balance exercise program.18
Ming-hsia et al in this study subjects received balance training which selectively manipulate sensory input from visual, vestibular and somatosensory system. Conclusion showed that balance training designed to improve intersensory interaction could effectively improve balance performance in healthy older adults.19
Ibrahimi N et al Studied the effect of sitting balance training under varied sensory input on balance and quality of life. Conclusion showed that balance training can be started early in rehabilitation program once sitting balance is achieved with altered sensory input for improving balance and quality of life.20
Hylton.B.Menz, Stephen R. lord et al studied to determine whether the application by passive tactile cues to lower limb could improve postural stability with diabetic neuropathy. These results have implication for novel approaches for improving stability in people with peripheral sensory loss.21
Mary P Thomson Julia potter et al studied to identify the threshold of reduced sensory perception in Type 2 DM using monofilament. This showed clinical detection of deteriorating sensory perception and enable implementation of foot protection strategies at an earlier stage than is currently practiced.13
Sangyeoup Lee, Hyeunho Kim et al found that the SW monofilament test was very sensitive and highly specific. Sensitivity and specificity at the third and fifth metatarsal head sites were comparable to those of 10 sites together. It is likely that the two-site SW monofilament test is useful clinically as a screening device for diabetic neuropathy as well as 10-site test. However, since this was done on small sample of Korean patients with type2diabetes,larger studies are warranted.22
Lisa Blum and Nicol Korner-Bitensky showed that berg balance scale is effective appropriate assessment of balance in stroke.23
Sarah F Tyson el al showed that berg balance test is reliable and valid measures of balance disability in post stroke.24
6.3AIM AND OBJECTIVES OF STUDY
To study the effectiveness of sensory re-education to improve balance in diabetic neuropathy.
7 /

MATERIALS AND METHODS:

7.1 STUDY DESIGN: Experimental comparative study.
SOURCE OF DATA: A.J Institute of Medical Science and Research Center.
SAMPLE SIZE : 30
7.2 METHOD OF COLLECTION OF DATA
SAMPLING TECHNIQUE
Simple random sampling.
INCLUSION CRITERIA
1.  Patient with diabetic neuropathy.
2.  Patient with age group of 45-65 will be included in this study.
3.  Both male and female included.
4.  Patient having diabetes since 10 years.
5.  Patient having both sensory and balance impairment.
6.  Patient with loss of protectitive sensation will be assessed by using Monofilament with 5.07/10g
EXCLUSION CRITERIA
1. Patient with foot ulcer at the moment of intake.
2. Patient with orthopedic problems influencing gait.
3. Patient with neurological problems influencing gait parameters.
4. Patient able to walk without any assistance.
5. Patient with vestibular problem.
6. Patient with visual problem.
MATERIALS
1.  Pen
2.  Paper
3.  Monofilament
4.  Tuning fork (250-300Hz)
5.  Fine brush
6.  Crude brush
7.  Sand paper
8.  Cotton
TECHNIQUE OF APPLICATION
METHOD
30 patients are randomly selected based on inclusion and exclusion criteria, sociodemographic data and medical history will be taken into consideration. Consent will be taken from the patient.
These 30 patients will be randomly allocated into two groups. 15 in group A and 15 in group B.
Group A: In this group balance training will be administered using balance protocol. Balance and sensation will be assessed pre and post.
Group B: In this group balance training using balance protocol and along with sensory re-education will be administered. Balance and sensation will be assessed pre and post.
Results will be compared between group A and group B.
PROCEDURE
Balance training protocol- consists of 14 exercises. Each exercise will be repeated 5 times. It will be given 5 times a week for 45 minutes for one month.
Sensory re-education- stroking with different texture will be given with frequency of is 3 to 5 strokes allowing 30 seconds to elapse between strokes and then repeat 3 to 5 times.
Vibration will be given by using tuning fork. It will be placed over the muscle belly, parallel with the muscle fiber. The duration of vibration should not exceed 1 to 2 minute per application.
Semmes Weinstein Monofilament testing: The 5.07/10 g SW monofilament is recommended by the International Diabetes Federation and the World Health Organization as a device that can be used to identify patients at risk of diabetic foot ulceration, as feasible by health care professionals at every level. The 10 g force SW monofilament will be used on ten sites of foot while patient will not be allowed to see at their feet during the test. 10 site are( dorsal surface of the foot between the base of the first and second toes, the first, third and fifth toes, the first, third and fifth metatarsal heads, the medial and lateral midfoot, and the heel in random order). Test sites will be prearranged to examine not only plantar but also various peripheral nerves and dermatomes of the foot. The SW monofilament will be pressed perpendicular to the test site with enough pressure to bend the monofilament for 1 sec. Patients will be asked to answer “Yes or No”, when felt or did not feel the press of the monofilament, respectively. If a patient did not perceive the filament at more than 4 out of 10 sites, that individual will be reported with sensory deficit and the site(s) will be recorded.
STUDY DURATION: Six months.
OUTCOME MEASURE
Berg Balance Scale.
Semmes Weinstein Monofilament.
STATISTICAL ANALYSIS
Student t test is used to compare between the groups.
Paired t test is used to compare pre and post within the group.
RESEARCH QUESTION
Will there be significant effect of sensory re-education to improve balance in diabetic neuropathy.
7.3 Does the study require any investigations or interventions to be conducted on
Patients or other humans or animals? If so, please describe briefly.
YES. Balance training and sensory re-education will be given to the patient. Berg balance scale will is used to assess balance and sensation will be assessed using Semmes Weinstein Monofilament.
Has ethical clearance been obtained from your institutions
Ethical clearance obtained
8 / List of References:
1. Vinik AI. Diabetic neuropathies. Med Clin North Am. 2004; 88(4):947-999.
2. Lt Gen SR Mehta et al .Diabetes Mellitus in India: The Modern Scourge. MJAFI,2009; Vol. 65, No. 1
3. S Ashok, M Ramu, R Deepa, V mohan. Prevalence of Neuropathy in Type 2 Diabetic patient Attending Diabetes Center in India. JAPI, April 2002; Vol. 50.
4. Horak FB, Dickstein R, Peterka RJ. Diabetic neuropathy and surface sway-referencing disrupt somatosensory information for postural stability in stance. Somatosens Mot Res. 2002; 19(4):316-26.
5. Susan B O Sullivan. Thomas J Schmitz .Physical Rehabilitation: assessment and treatment: fifth edition.
6. Curfinkel VS, lvanenko YP, Levik YS, Babakova IA. Kinesthetic reference for human orthograde posture. Neuroscience. 1995; 68:229-243.
7. Simoneau GG, Ulbrecht JS, Derr JA, Cavanagh PR. Role of somatosensory input in the control of human posture. Gait Posture. 1995; 3:115-122.
8. R.W.M van Deursen et al. Foot and Ankle Sensory Neuropathy, Propriception, Postural Stability. Journal of Orthopedic & Sports Physical Therapy 1999; 29(12):718-726.
9. Gandevia SC, Burke D. Does the nervous system depend on kinesthetic information to control natural limb movements? Behave Brain Sci 1992; 15:614-632.
10.Boucher P, Teasdale N, Courtemanche R, Bard C, Fleury M. Postural stability in diabetic polyneuropathy. Diabetes Care. 1995; 1 8:63&645.
11. Uccioli L, Giacomini PG, Monticone G, et al. Body sway in diabetic neuropathy. Diabetes Care. 1995; 18:1339-344.
12. Yentes, Jennifer M. et al.Diabetic peripheral neuropathy and exercise. Clinical Kinesiology: Journal of the American Kinesiotherapy Association >September 22, 2006.
13. Mary P Thomson, Julia Potter et al .Threshold for detection of diabetic sensory neuropathy using a range of research grade monofilament in person with Type 2 diabetes mellitus. Journal of Foot and Ankle Research. 2008; 1:9 doi: 10.1186/1757-1146-1-9.
14. Snehal Bhupendra Shah et al. Study of balance training in ambulatory hemiplegics. The Indian Journal of Occupational Therapy. 2006; Vol. XXXVIII: No. 1
15. Tanja Oud et al. Sensory re-education after nerve injury of upper limb: a systematic review. Clinical Rehabilitation June 2007; Vol. 21 no. 6 483-494.
16. Lynch EA, Hillier SL, Stiller K, Campanella RR, Fisher PH. Sensory retraining of the lower limb after acute stroke: a randomized controlled pilot trial. Arch Phys Med Rehabil 2007; 88:1101-7.
17. Allet L et al .The gait and balance of patient with diabetes can be improved : a randomized control trial. Diabetologia. 2010 Mar; 53(3): 458-66.
18. Kelly Westlake and Elise G Culham . Sensory – specific balance training in older adults ; Effect on propriceptive reintegration and cognitive demands. Journal of American Physical Therapy Association. October 2007; vol. 87 no. 10 1274-1283.
19. Ming-hsia hu et al. Multisensory training of standing balance in older adults: .Postural stability and one-leg stance balance. Journal of Gerontology. 1993; vol 49 issue 2 Pp. M52-M61.
20.Ibrahimi N et al.Effect of sitting balance training under varied sensory input on balance and quality of life in stroke patient. Indian Journal of Physiotherapy and Occupational Therapy Year. 2010; Volume : 4, Issue : 2.
21. Hylton B. Menz et al. A Tactile stimulus applied to the leg improves postural stability in young, old, neuropathic subjects October. 2006; Volume 406, Issues 1-2, Pages 23-26.
22. Sangyeoup Lee et al. Clinical usefulness of two-site Semmes Weinstein Monofilament test for detecting diabetic peripheral neuropathy. Journal of Korean Medical Science. 2003; 18: 103-7 ISSN 1011-8934.
23. Blum, Lisa, Korner Betensky et al. Usefulness of berg balance scale in stroke rehabilitation. a systematic review. American Physical Therapy Association.
24. Sarah F Tyson et al. Reliability and validity of functional balance test post stroke. Clinical Rehabilitation August 2004; Vol.18 no. 8 916-923.