Efficacy of Vibrating Insole Versus Biodex System on Postural Control in Patient with Diabetic Neuropathy

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1 Med. J. Cairo Univ., Vol. 84, No. 2, March: , Efficacy of Vibrating Insole Versus Biodex System on Postural Control in Patient with Diabetic Neuroathy NAWAL ABO SHADY, Ph.D. 1 ; NEVEEN EL FAYOUMY, Ph.D. 1 and HOSSAM M. ALSAID, M.Sc. 2 The Deartments of Physical Theray for Neuromuscular Disorder & Its Surgery, Faculy of Physical Theray, Cairo University 1 and Clinical Neurohysiology, Faculty of Medicine, Cairo University 129 Periheral neuroathy (PN) is damage to nerves of the eriheral nervous system, which may be caused either by neurological diseases, trauma to the nerve or as acomlication of systemic illness [3]. Diabetic sensory olyneuroathy (DSP) is a major risk factor for the develoment of lanter ulceration because of the imairment of rotective sensation [4]. Moreover, neuroathy which gives dry fissured skin that leads to abnormal ressure distribution in the foot when standing or walking [5]. Patients with diabetes and eriheral neuroathy had greater ostural sway in quiet standing and greater difficulty integrant sensory information for balance Control than healthy control subjects. The investigators found that ostural control is related to the severity of eriheral neuroathy [6]. Patients with diabetic neuroathy demonstrate arelative deficit in their ability to maintain osture. Biodex balance system allows an early disclosure of the failure of ostural control [7]. Postural control mechanisms are deending on feedback system. It is based on ostural sway information detected from visual, vestibular and eriheral recetors [8]. Somatosensory information from the lower extremities is one of the main inut sources that ensure and regulate ostural control [9]. Proriocetion is the body s ability to transmit osition sense, interret the information and resond consciously or unconscionsly to stimuation through aroriate execution of osture and movement. Proriocetion lays an imortant role in maintaining balance, enabling to jum, run, throw, and knowing the osition of body arts without looking at them [1].

2 13 Efficacy of Vibrating Insole Versus Biodex System on Postural Control Patients and Methods Patients: Fourty five atients (males and females) with age ranged from 5-65 years and resented clinically with diabetic heriheral neuroathy (DPN) articiated in this study. The atients were selected from outatients clinics of neurology, internal medicine deartments, Cairo university hositals, the outatients clinic, and from the faculty of hysical theray, referred by the hysician from July 215 to January 216. The atients were diagnosed as having sensory olyneuroathy secondary to diabetes mellitus based on careful neurological assessment and confirmed by nerve conduction studies. Particiants met the following inclusion criteria: All atients have tye II DM with symtoms and signs of mild and moderate eriheral neuroathy, atients with mild (grade one) and moderate (grade two) eriheral sensory neuroathy according to grading of neuroathy scale (Aendix II) [11]. (1) Age of these atients ranged from 5-65 years. (2) Diabetic neuroathy started from 1-2 years. (3) All atients are medically stable with medical examination. (4) Able to understand instruction and follow commands. (5) All atients able to standalone (6) All atients must have different educational level. (7) There is no motor imairment according to JAMAR dynamamometer used to measure the muscle strength. (8) Degree of sensory imairment (Level I, II) according to grading of neuroathy scale (11). (9) The body mass index (BMI) below 3kg/m 2. Exclusion criteria include atients who had (1) Patients with tye I diabetes mellitus. (2) Patients with severe visual and vestibular roblem. (3) Patients with serious chronic illness that may interfere with the assessment. (4) Presence of foot ulcers. (5) Significance feet deformities, other neurological disorders as stroke, Ms. (6) Acute nerve root comression (radiculoathy). (7) Severe knee osteoarthritis. (8) Periheral vascular disease as varicose veins. (9) Recent or old mal union fractures of lower limbs. (1) Patients with cognitive and sychiatric roblems. (11) Lower limb injuries or oerations or using assistive devices as braces. Instrumentation: 1- Biodex balance system (Biodex-medical system. Inc., Brook Baren R and D Plaza, 2 Ramsey road, box 72, Shirley, New York ). Was used for assessment of static balance o atients with diabetic neuroathy. 2- Berg balance scale: The berg balance scale (BBS) is a functional based assessment scale. BBS is widely used clinical test of erson s static and dynamic balance abilities. 3- Weight and height scale is valid and reliable weight and height scale was used for measurement of The weight and height of the atients to calculate the body mass index (BMI) before conduction of the study. 4- Vibrating insole is awearable, batter oerated vibratory device (VD) delivers vibrations stimulus to the soles that is synchronized with the a atients feet (Fig. 3). Three VDs were embedded in each insole the device includes a vibrator or stimulator, which is a small vibrating disk motor such as otec 289WII (Otec Co. Ltd., Jaan), vibrating at a frequency of 7HZ and oerating at 1.3 V for each insole, three vibratory units were used, below the heel and two below the forefoot. Referring to figure eight vibratory device includes a vibration disk motor with a diameter of.5cm). A switch is rooted in otable device which generates, vibrating stimulus through leads injected to vibrating device thickness of vibrating device is aroximately.8 cm and weight of aroximately ten grams. (Fig. 9) VD was used for treatment in study grou (I) to imrove balance and somatosensory awareness [12]. Procedure: A- Evaluation session: Measurement of standing balance by Biodex balance system all atients were submitted to comlete clinical neurological assessment according to standard clinical evaluation neurological sheet and berg balance scale is a ruler, two standard chairs (one with arm rests, one without), footstool or ste, sto watch or wrist watch with a second hand, 15 foot (ft) walkway were used for the alication of the BBS. The normal timing to comlete each item on the scale ranged from 15-2 minutes. Each atient was asked to erform every task on the BBS as written in the scale. The scoring system ranged from zero-four Zero indicated the lowest level of function. Total score = 56 This test was erformed re and ost treatment rogram for each atient in three grous (A,B,C). Patients who had scores more than 41 oints were articiating in this study [13]. B- Training session: Patients were assigned into three grous equal in number: Study grou (A): (11 male and 4 female) received vibrating insole training with vibrating device for 18 sessions (every other day) the duration

3 Nawal Abo Shady, et al. 131 of session was 15 minutes. The study grou (A) received additional selected hysical theray rogram for DPN atients (Proriocetive training). Study grou (B): (7 male and 8 female) received visual feedback training with Biodex balance system for 18 sessions (every other day) the duration of session ten minutes and reeated for three times as a total duration of session was about 3 minutes. The study grou (B) received additional selected hysical theray rogram or DPN atients (roriocetive training rogram). Control grou (C): (1 male and 5 female) received the same selected hysical theray rogram for DPN atients (roriocetive training rogram) only without vibrating insole nor biodex balance system. Statistical analysis: The statistical methods for analysis of the results were used according to the following Data was summarized using range, mean and standard deviation for quantitative variables and frequency and ercentage for qualitative ones. Descritive statistics and ANOVA-test for comarison of the mean age, weight, height, and BMI between the three grous. Paired t-test for comarison between re and ost treatment mean s in each grou. ANOVA-test for comarison of re and ost treatment mean s between grous. The level of significance for all statistical tests was set at <.5. All statistical measures were erformed through the statistical ackage for social studies (SPSS) version 19 for windows. Results Comaring the general characteristics of the subjects of the three grous revealed that there was no significance difference between the three grous in the mean age, weight, height, and BMI (>.5). Table (1): Descritive statistics and ANOVA test for the mean age, weight, height, and BMI of grou A, B, and C. X±SD X±SD X±SD F- - Age (years) 58.66± ±3.43 6± NS Weight (kg) 72.4± ± ± NS Height (cm) 168.2± ± ± NS BMI (kg/m 2 ) 25.66± ± ± NS X: Mean. SD: Standard deviation. -: Probability. NS: Non significant. Table (2): The frequency distribution of sex in of the three grous (A, B, and C). Female Male Female Male Female Male No. (%) Total 4 (27%) 11 (73%) 8 (53%) 7 (47%) 5 (33%) 1 (67%) 15 (1%) 15 (1%) 15 (1%) 73% 27% 47% 53% 67% 33% Female Male Fig. (1): Sex distribution of grou A, B, and C.

4 132 Efficacy of Vibrating Insole Versus Biodex System on Postural Control Table (3): Comarison of duration of illness between the three grous (A, B, C). Grou A Grou B Grou C F 7.2± ± ± Duration of illness (months) Duration of illness (months) X: Mean. SD: Standard deviation. -: Probability. NS: Non significant NS Fig. (2): Mean duration of illness (months) of grou A,B,C. II- Pre treatment mean s of overall stability of grou A, B, and C: The mean ± SD overall stability re treatment of grou A, B, and C were 27.93±7.74, 26.6±4.28, and 28.4±6.55 resectively. There was no significant difference in the overall stability between the three grous re treatment (=.72). (Table 5, Fig. 4). Table (5): Comarison of re treatment mean s of overall stability between the three grous (A, B, and C). Overall stability Grou A Grou B Grou C F 27.93± ± ± X: Mean. SD: Standard deviation. -: Probability. NS: Non significant NS Comarison between grous re treatment: I- Pre treatment mean s of berg scale score of grou A, B, and C: The mean ± SD berg scale score re treatment of grou A,B, and C were 41.26±.88, 41.46±1.35, and 4.73±1.7 resectively. There was no significant difference in the berg scale score between the three grous re treatment (=.32). (Table 4, Fig. 3). Overall stability 2 1 Table (4): Comarison of re treatment mean s of berg scale score between the three grous (A,B, and C) ± ± ±1.7 Berg scale score F NS Berg scale score X: Mean. SD: Standard deviation. -: Probability. NS: Non significant. Fig. (3): Pre treatment mean s of berg scale score of grou A, B, and C. Fig. (4): Pre treatment mean s of overall stability of grou A, B, and C. Comarison between grous ost treatment: I- Post treatment mean s of berg scale score of grou A, B, and C: The mean ± SD berg scale score ost treatment of grou A, B, and C were 45.33±1.34, 54.86±1.24, and 43.93±3.32 resectively. There was a significant difference in the berg scale score between the three grous ost treatment ( =.1). (Table 6, Fig. 5). The mean difference between grou A and B was There was a significant increase in berg scale score of grou B comared with grou A (=.1). The mean difference between grou A and C was 1.4. There was no significant difference in berg scale score between grou A and grou C (=.8). The mean difference between grou B and C was There was a significant increase in berg scale score of grou B comared with grou C (=.1).

5 Nawal Abo Shady, et al. 133 Table (6): Comarison of ost treatment mean s of berg scale score between the three grous (A,B, and C). Table (7): Comarison of ost treatment mean s of overall stability between the three grous (A, B, and C). Berg scale score Overall stability F F 45.33± ± ± S 33.2± ± ± S Grou A - Grou B Grou A - Grou C Grou B - Grou C Multile comarison (LSD) Multile comarison (LSD) MD - MD S NS S Grou A - Grou B Grou A - Grou C Grou B - Grou C S NS S X: Mean. -: Probability. SD: Standard deviation. NS: Non significant. X: Mean. -: Probability. SD: Standard deviation. NS: Non significant. S: Significant. Table (8): Correlation between berg scale and balance system assessment. Berg scale score r Overall stability.47.1 S Forward stability.46.1 S Berg scale Backward stability.41.1 S Right stability.5.1 S Left stability.49.1 S r-: Correlation coefficient. -: Probability. S: Significant. Fig. (5): Post treatment mean s of berg scale score of grou A, B, and C. II- Post treatment mean s of overall stability of grou A, B, and C: The mean ± SD overall stability ost treatment of grou A, B, and C were 33.2±8.21, 38.86±8.16, and 31.33±6.19 resectively. There was a significant difference in the overall stability between the three grous ost treatment ( =.2). (Table 7, Fig. 6). The mean difference between grou A and B was There was a significant increase in overall stability of grou B comared with grou A (=.4). The mean difference between grou A and C was There was no significant difference in overall stability between grou A and grou C (=.5). The mean difference between grou B and C was There was a significant increase in overall stability of grou B comared with grou C (=.9). Overall stability Berg scale Fig. (6): Correlation between berg scale and overall stability. Discussion The results of the current study showed that the vibrating insole have a ositive effect on the standing balance of atients with diabetic neuroathy. This can be attributed to enhancement of corticosinal excitability and increase tonic activities in the foot muscles in resonse to vibration in DPN atients. This agrees with Thomson et al. [14] who started that increased tonic activities in the muscles could result in the aearance of a tonic vibration reflex (TVR) within the trices Surae muscle grou. According to Derak et al. [15].

6 134 Efficacy of Vibrating Insole Versus Biodex System on Postural Control Vibration is associated with extensive sensory stimulation. Efficient use of the roriocetive feedback loo could modify the cortico-sinal outut and muscles activities. This also agrees with Santos et al. [16]. The authors attributed the otent effect of external stimuli on the standing balance in DPN atients to the efficacy of attention in generating cortical lasticity in the rimary somatosensory and motor cortex and imrovement in the motor memory. The imrovement in the DPN atients in the resent study can also be attributed to the otent effect of external cues on activating alternate athway contains sensorimotor cortex. The remotor cortex may be resonsible for scaling the balance activity when facilitated by somatosensory cues related to task (standing). This tends to be consistent with Haslinger et al. [17]. These results contradict with Yogev et al. [18] who announced that external cues suort a more automatic form of motor control in consistency may results from the use of dual tasks in Yogev et al. [18]. The ositive effect of the otentiated roriocetive feedback on the standing balance this study focused on the transfer of cued learning to diabetic neuroathy Pataky et al. [19]. The results of the current study come line with Salsabili et al. [2], who found effective balance trainings by Biodex Balance system treat contextsecific instabilities of ostural control in atients with DPN, by lacing more emhasis on somatosensory information in balance training. By means of these trainings, the balance training methods borrowed from reactive movement strategies and sensory strategies for evoking somatosensory information regarding the guiding contributions of external visual biofeedback. In this study, atients with DPN imroved their Balance system. Nicolas et al. [21] suggested the introduction of an original biofeedback system of Biodex device form imroving balance control. The rogression aimed at roviding additional sensory information related to foot sole ressure distribution to the DPN atients, through a tongue laced tactile outut device to imrove ostural control during quit standing. This means that, when treated abnormal foot ressure in DPN atients by using insole tactil foot ressure device connected to screen as biofeedback leading to imrovement of balance control. Visual feedback has an effect on the balance imairment in atients with PN as a result of Tye I DM as well. This was documented by Muhammed [22] by using electrical balance board connected with comuter as its screen acts as visual feedback. Vision aly direct role in stabilizing the balance by roviding the nervous system with continually udated information regarding the osition and movement of body segments in relation to each other and environment. When atients stand with closed eyes, the osture sway will increase between 2% to 7% this study also found that moving visual field can induce a owerful sense of self motion and misleading visual cues induce significant increase in osture sway. Jon et al. [23] also found that balance training and imrovement of trunk control by using balance board exercise in the form of forward backward and side to side trunk movement has an effect on the distribution of standing weight bearing of atient. The Authors conducted the study on 45 DPN atients within duration 18 weeks for reducing ostural sway during quiet standing. Brooks [24] Found that there was a significant imrovement of ankle ROM at the end of balance treatment in the form of roriocetion exercise for three months in the DPN atients. This indicated that the alication of balance training was effective in increase ROM that lead to imrovement of standing balance. The results of current study disagree also with the fining of Santos et al. [16], the authors found that the roriocetive training among diabetic women was effective in increasing the lanter tactile sensitivity. Balance rogram was effective also in reducing the antero osterior oscillation of the center of ressure oscillatory amlitude in the biedal osition with eyes oen after 18 weeks of training. Conclusion: Based on the score and findings of this study, it was concluded that visual feedback training of biodex device is much better than vibrating insole on standing balance in atients with diabetic neuroathy. References 1- ANDREW J.M. and BOULTON M.D.: Management of Diabetic Periheral Neuroathy. Clinical Diabetes, 23: 9-15, HERMAN W.H., AUBERT R.E., ENGELGAU M.M., THOMPSON T.J., ALI M.A., ER A.M., BRECHNER R.J., WETTERHALL S.F., DeSTEFANO F., SMITH P.J.,

7 Nawal Abo Shady, et al. 135 HABIB M., ABD EL SHAKOUR S., IBRAHIM A.S. and EL BEHAIRY E.M.: Diabetes mellitus in Egyt: Glycaemic control and microvascular and neuroathic comlications. Diabet. Med., 15: , CHETLIN R.D., GUTMANN L., TARNOPOLOSKY M., ULLRICH I.H. and YEATER R.A.: Resistance training effectiveness in atients with Charcot-Marie-Tooth disease: Recommendations for exercise rescrition. Arch. Phys. Med. Rehabil. Aug., 85 (8): , McGUIRE J. and NAWOCZCNSKI D.: The biomechanical management of diabetic foot ulcers. West Indian Med. J., 5 (I): (Abstract), LEONARD D.R., FAROOQI M.H and MYERS S.: Restoration of sensation, reduced ain, and imroved balance in subjects with diabetic eriheral neuroathy: A duble bind ranged lacebo controlled study with mono chromatic infrared treatment. Diabetes Care, 27: , LAFOND D., CORRIVEAU H. and PRINCE F.: Postural control mechanism during quiet standing in atients with diabetic sensory neuroathy. Diabetes Care, 27: , UCCIOLI L., GIACOMINI P.G., MONTICONE G., MA- GRINI A., DUROLA L., BRUNO E., PARISI L., Di GIROLAMO S. and MCNZINGER G.: Body sway in diabetic neuroathy. Diabetes Care, Mar., 18 (3): , PETERKA R..: Sensorimotor integration in human ostural control. J. Neurohysiol., 88 (3): , JAMES E., ROBERT B. and HODGES W.: Dorsiflexion metatarsal osteotomy for treatment of recalcitrant diabetic neuroathic ulcers. Foot and Ankle Int., 2 (2): 8-85, HOUGLUM and PEGGY A.: Theraeutic excesses for Athletic injuries. Human Kinetics 28, Chamagin IL. P , ALMADRONES, CALHOUN and CELLA: Tools for grading neuroathy scale, Descrition of Tools. The National Cancer Institute s, De NUNZIO A., GRASSO M., NARDONE A., GODI M. and SCHIEPPATI M.: Alternate rhythmic vibration stimulation of trunk muscles affects walking cadence and velocity in arkinson s disease. Clin. Neuroathysio., 121 (2): 24-7, Berg K.O., S.L. WOOD-DAUPHINESE, J.I. WILLIAMS and B. MAKI: Measuring Balance in the Elderly. Valida- tion of an instrument Archives of Physical Medicien and Rehabilitation, 85 (7) (July 29): , THOMPSON C., BE' LANGER M. and FUNG J.: Effect of bilateral Achilles tendon vibration on ostural orientation and balance during standing, clinical neurohysiology, 118: , DERAK: Video feedback. Retrieved from Gait Posture, (12:28), SANTOS A.A., BERTATO F.T., MONTEBELO M.I.L. and GUIRRE E.C.O.: Effect of roriocetive training among diabetic woman, Vol., 12 No. 3, HASLINGER B., ERHARD P., KAMPFE N., BOECKER H., RUMMENY E., SCHWAIGER M., CONRAD B. and CEBALLOS-BAUMANN A.: Event related functional magnetic resonance imaging in Parkinson s disease before and after levodoa. Brain, 124: 558-7, YOGEV G., GILADI N., PERETZ C., SPRINGER S., SIMON E. and HAUSDORFF J.: Dual tasking, gait rhythmicity, and Parkinson s disease: Which asects of gait are attention demanding? Euroean ournal of Neuroscience, 22: , PATAKY Z., ASSAI J.P., COONE P., VUAGNAT H. and GOLAY A.: Plantar ressure, distribution in Tye 1 diabetic atients without eriheral neuroathy and eriheral vascular disease. Diabet. Med. Jun., 22 (6): 762-7, SALSABILI HODA M.S. FARID BAHRPEYMA, Ph.D., BIJAN FOROGH, M.D. and SANAZ RAJABALI M.S.: Dynamic stability training imroves standing balance control in neuroathic atients with tye II diabetes. J. Rehahil Res. Dev., 48 (7): , NICOLAS VUILLERME, OLIVIER CHENU, JACQUES DEMONGE and YOHAN PAYAN: Effect of introducing an original biofeedback system for imroving balance control in addition to sensory information related to foot sole ressure distribution. Diabetes Metab. Res. Rev., Aril, 16 (4): 19-44, MUHAMMAD S.T.: Effect of visual feedback on balance in atients with diabetic neuroathy, Thesis from faculty of hysical theray Cairo University, , JON R., ROY H. and SUSAN S.: The effects of range of motion theray on the lantar ressures of atients with diabetes mellitus. JAOMA, 92 (9): , BROOKS G.: Effects of balance training on the foot ressure in diabetic eriheral neuroathy atients during walking. J. Ortho. Srts Phys. Ther., 25: , 214.

8 136 Efficacy of Vibrating Insole Versus Biodex System on Postural Control