RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
1. / Name of the candidateand Address /
KAZI ZEBA BASIR AHMED
DR. M.V. SHETTY COLLEGE OF PHYSIOTHERAPY,KAVOOR,
MANGALORE-575001
2. /
Name of the Institute
/ DR. M.V. SHETTY COLLEGE OF PHYSIOTHERAPY, MANGALORE.3. /
Course of study and
Subject / MASTER OF PHYSIOTHERAPY (MPT)“PHYSIOTHERAPY IN NEUROLOGY AND PSYCHOSOMATIC DISORDERS.”
4. /
Date of Admission
To course / 13 JULY, 20125. /
Title of the Topic
/ INFLUENCE OF SPIKED INSOLES ON PLANTAR CUTANEOUS SENSITIVITY AND BALANCE IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY.6. /
Brief resume of the intended work:-
6.1 Introduction and Need for the study :Diabetes is a non communicable disease that have many secondary complications including Diabetic Peripheral Neuropathy (DPN). Prevalence of diabetes has significantly increased in world population..1,2 Most alarming is the steady increase in type 2 diabetes, especially among young and obese persons. Diabetes peripheral neuropathy (DPN) is the most common peripheral nervous system disorder.3. It is estimated that between 12 and 50% of people with diabetes have some degree of DPN.4
ANNEXURE II
7.8. / DPN can lead to loss of sensation, loss of muscle strength, pain and increase risk of falling.5,6,7. It is well established that plantar cutaneous information participates, among sensory input to postural stability8,9. Diabetic patients with peripheral neuropathy demonstrate a relative deficit in their ability to maintain posture because both the afferent and efferent pathways are disrupted.10
In addition, instability in diabetic peripheral neuropathy is can be due to loss of plantar cutaneous sensation.11
NEED OF STUDY :
A study to assess immediate effects of spiked insoles and textured surface on balance and plantar cutaneous sensitivity (PCS), showed that when using spiked insoles, balance and PCS is improved.12 Authors suggested to carry a further research in individuals affected with diabetic peripheral neuropathy.
However it is still not clear whether spiked insoles can improves balance and plantar cutaneous sensitivity in patients with Diabetic peripheral neuropathy.
Hence, need was identified to assess the efficacy of spiked insole in improving plantar cutaneous sensitivity and balance.
Research Question :
Will there be any influence of spiked insoles on plantar cutaneous sensitivity and balance scores in patients with diabetic neuropathy?
Hypothesis :
Alternate hypothesis: (H1)
Spiked insoles improve plantar cutaneous sensitivity and balance in patients diabetic peripheral neuropathy .
Null hypothesis: (H0)
There is no effect of spiked insole on plantar cutaneous sensitivity and balance in patients with diabetic neuropathy.
6.2) Review of Literature :
Diabetes is rapidly emerging as a Global health care problem and its prevalence has been increased since year 2000 and its estimated to increase up to 366 million by 2030.13 India has a high prevalence of Diabetes Mellitus and the numbers are increasing at an alarming rate and since DPN seems to be quiet common in India, number of patients that are affected by lower extremity peripheral neuropathy is as twice as common in diabetic patients, compared with non-diabetic individuals and it affects 34.9% of diabetic patients
who are older than 40 years.14 wherein men and women have equal frequency.15
DPN mainly affects foot by damaging nerves which consequently affects plantar propioception and sensation, decreased stability has been noted in standing balance of diabetic peripheral neuropathy patients.16 Increase of postural sway is observed in diabetic neuropathic patients and in elderly patients, can be partially explained by loss of tactile sensation. Both touch and vibratory threshold decline with age.17
Adding texture to the upper surface of shoe insoles has been hypothesised to increase sensory afferent feedback via enhanced tactile stimulation of plantar cutaneous mechanoreceptors.18,19 Textured floor surface and textured spike insoles were reported to improve static and dynamic balance in young adults and elderly individuals where significant reduction in gait velocity, step-length, stride-length was noted, thereby reducing incidence of falls in elderly.20
A study was done to investigate subsensory mechanical noise applied to the soles of the feet via vibrating insoles can be used to improve quiet-standing balance control in 15 patients with diabetic neuropathy and 15 patients with stroke. Sway data of 12 healthy elderly subjects from a previous study on vibrating insoles were added for comparison.
Result shows that application of vibrating insoles leads to statistically significant reduction
in each of the 8 sway parameters in the subjects with diabetic neuropathy, the subjects with stroke, and the elderly subjects.21
Few researchers also evaluated the effects of rotary plantar massages with use of mechanical plantar stimulater,on balance parameters like sway area in anterior posterior and medio-lateral axis and Center of pressure, in elderly and young adults and it is concluded that 10 minutes of tactile plantar stimulation improves balance parameters by re organization of the control mechanisms for maintaining undisturbed upright stance. Older adults with superficial plantar sensory deficit may benefit even more than young and elderly subjects from sensory feedback as a plantar input reinforcement and/or proprioceptive cue substitution for diminished foot CoP information. 22
The role of tactile signals has also been explored by changing characteristics of supporting surface. For eg. Standing on Array of ball-bearing, on pins or on randomly knobbed surfaces located on the plantar surface boundaries. This change in supporting surface may lead to increased plantar sensation and thereby balance.23,24,25
Juha Hijmans,Jan Geertzen, Pieter Dijkstra, Klaas Postem identified and reviewed various publications on effects on ankle and foot appliances on balance in older people (> 60 years) & DPN patients. They concluded that insoles may improve balance & need of immediate effects of Ankle foot orthoses (AFA) like insoles is required in individuals affected with sensory loss due to Diabetic neuropathy. 26
Therapeutic effects of wearing randomly spiked insoles for 5 weeks along with sensory training in children (age 6-8 years) has shown significant improvement in sensory thresholds and motor co ordination ability in children.27
For balance testing, the clinical test of Sensory Interaction and Balance (CTSIB) has been widely used clinically by physical and occupational therapists.28,29
A study determined that if timed balance scores on modified clinical test of sensory interaction and balance were affected by shoe wear in patients with balance and vestibular disorders and also checked if there is a difference in correlation with the sensory organization test or in sensitivity or specificity based on footwear. They found out that there existed no difference in scores of modified CTSIB with shoes on versus off. Hence, modified CTSIB can be performed with insoles on, with no difference expected in patient score or test sensitivity or speificity.30
Plantar cutaneous sensitivity can be assessed using Semmes-Weinstein monofilaments by following appropriate procedure developed to check plantar cutaneous sensitivity in DPN individuals.31
6.3) Objective of the study :
1. To assess effectiveness of spiked insoles on plantar cutaneous sensitivity in patients with diabetic peripheral neuropathy.
2. To assess effectiveness of spiked insoles on balance in patients with diabetic peripheral neuropathy.
Materials and Method:
7.1) Study design:
Experimental study design
7.2) Source of data :
Patients diagnosed with Diabetic Peripheral Neuropathy referred by specialists for physiotherapy.
7.2 (I) Definition of study subjects:
Subjects 40 years and above with confirmed diagnosis of Diabetic Neuropathy.
7.2 (II) Inclusion and Exclusion criteria:
INCLUSION CRITERIA:
· Both gender
· Confirmed diagnosis of type-2 Diabetes with Neuropathy
· Informed consent
· Age >40 years.
· Medically confirmed Diabetes Mellitus with Peripheral Neuropathy.
EXCLUSION CRITERIA:
· Diagnosis of Dementia or Cognitive Deficits
· Severely impaired visual or auditory acuity
· Lower limb or upper limb amputation at any level
· Lack of independent ambulation
· Chronic alcoholism
· Artificial joints
7.2(III) Study Sampling Design, Method and Size:
Sample size: 40 Subjects fulfilling the inclusion criteria.
Sampling design and method: Pre and Post test, cross over study design method will be used for sampling.
7.2(IV) Outcome measure used:
Semmes Weinstein Monofilament for testing plantar cutaneous sensitivity and modified CTSIB SCALE for checking balance.
7.2(V) PARAMETERS USED FOR COMPARISON AND STATISTICAL TEST:
Collected data will be analyzed by mean, standard deviation and by Student’s ‘T’ test.
7.2(VI) Duration of the study:
Data will be collected over the period of approximately 12 months.
7.2(VII)Methodology:
Subjects meeting the inclusion criteria will be recruited for the study. Informed consent will be obtained from the subjects.
Instruments to be used:
Ø stopwatch
Ø foam
Ø Spiked insoles
Ø Semmes-Weinstein monofilaments
Ø Paper and pen.
PROCEDURE:
Method of collection of data:
Forty participants of both males and females over age group > 40 years that meets inclusion criteria will be considered. Prior to the intervention an informed written consent will be taken from the participants.
A pre-participation testing will be done which will include sensitivity testing to assess plantar cutaneous sensation and modified CTSIB testing to check balance. After pre-participation test, DPN patients are made to wear their normal insoles for 10 minutes, 5 minutes for standing and 5 minutes for walking. After the 10 minutes post participation PCS sensitivity and modified CTSIB score is noted. At the subsequent session, patients are made to wear spiked insoles for 10 minutes, 5 minutes for standing and 5 minutes for walking. After giving 10 minutes of intervention post participation PCS sensitivity and modified CTSIB score is noted. Data would be compared for differences between the two sessions.
Modified CTSIB is a shortened version of Clinical test for sensory interaction nd balance (CTSIB).This balance score testing is done as it is more effective than CTSIB, valid for current clinical practices with footwear on. It has more feasibility and reliability compared to other scales.
Time required to perform this test is 10 minutes to measure static balance and it considers only four components out of clinical test of sensory interaction and balance (CTSIB).
SCORING : 3 trials of max 30 sec are permitted for each condition, if unable to maintain standing for 30 sec, instability is considered.
Modified CTSIB:
CONDITION 1 :
EYES OPEN, FIRM SURFACE
Examiner Instructions: Record the time the patient is able to stand to a maximum of 30 seconds.
Patient: Place your hands on your hips. Place your feet together until almost touching. Look straight ahead. Each time, stay as stable as possible until I say stop.
CONDITION 2 :
EYES CLOSED FIRM SURFACE
Same instruction will be followed with eyes closed
CONDITIOIN 3 :
EYES OPEN, FOAM SURFACE
Examiner Instructions: Place foam. Assist subject in stepping onto foam.
Tell patient to “Open Eyes” Record the time the patient was able to stand in each condition to a maximum of 30 seconds. Have the subject step off the foam between trials. Include leaning or hip strategy during a trial as “instability.”
Patient: Place your hands on your hips. Place your feet together until almost touching. Look straight ahead. Each time, stay as stable as possible until I say stop.
CONDITION 4 :
EYES CLOSED ON FOAM SURFACE.
Same instructions will be followed with Eyes closed.
SENSORY EVALUATION :
Fine-touch sensitivity would be assessed by probing both feet at four different foot sole locations [great toe, first metatarsal head (MT), fifth MT, heel]. The test would be performed before (pre-test sensitivity) and after (post-test sensitivity). Both assessments would be done without insoles. Participants would be seated blindfolded and informed about the beginning of the testing period and areas to be stimulated. They would be instructed to indicate whenever stimulation was perceived.
A maximum of 3 stimulations per monofilament would be applied on each area. The sensitivity threshold would be determined by the thinnest monofilament that is detected at least once.
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.
Modified clinical test of sensory interaction and balance and plantar cutaneous sensitivity test.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES
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