DEWA PUTU SUTJANADEWA PUTU SUTJANADEWA PUTU SUTJANADEWA PUTU SUTJANA I PUTU GEDE ADIATMIKAI PUTU GEDE ADIATMIKAI PUTU GEDE ADIATMIKAI PUTU GEDE ADIATMIKA

I GUSTI NGURAH ARDANAI GUSTI NGURAH ARDANAI GUSTI NGURAH ARDANAI GUSTI NGURAH ARDANA I. B. K. GEDE DHARMA PUTRAI. B. K. GEDE DHARMA PUTRAI. B. K. GEDE DHARMA PUTRAI. B. K. GEDE DHARMA PUTRA

Udayana University PressUdayana University PressUdayana University PressUdayana University Press

ISBN NoISBN NoISBN NoISBN No: 978: 978: 978: 978----602602602602----8566856685668566----85858585----8888

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Gait Analysis Of The Prosthesis Prototype Made From The Natural Fiber

Reinforced Composite

Agustinus P. Irawan, Tresna P. Soemardi*, Widjajalaksmi K.** , Agus H.S. Reksoprodjo*** Department of Mechanical Engineering, University of Indonesia and University of Tarumanagara,

Jakarta, Indonesia, *Department of Mechanical Engineering, University of Indonesia, Depok, Indonesia, **Faculty of Medicine, University of Indonesia, Jakarta, Indonesia, ***Department of

Mechanical Engineering, University of Indonesia, Depok, Indonesia

In patients who use the prosthesis, gait analysis is an activity to observe the pattern of walking use the prosthesis for the patient. This activity aims to obtain information relating to balance, comfort, ease of use and the possibility of disorder experienced by the patient during walking using a prosthesis. This study aims to perform gait analysis of lower limb prosthesis, which was developed from ramie fiber composite materials (RE), especially in the socket component. The methods used in gait analysis is the patient walk on a path that has been determined for 6 minutes for each prosthesis produced. Gait analysis data include steps total, cadence (steps/min), step time (s), right step length (cm), left step length (cm), the step width (cm), stride length (cm), stride total, walking length total (m), walking length total per minute (m), walking speed (m/s). Based on the analysis of test results that have been done, it can be concluded that the prosthesis produced from RE has a good comfort level. Prototype with a socket prosthesis produced of RE is lighter, stronger and more elastic compared with socket produced of FGP and ramie RP. This condition greatly affects the comfort level felt by the respondents. Keywords : gait analysis, prosthesis, socket, ramie epoxy composite, comfort.

Introduction

Prosthesis is a component of the human body replacement. One of the most used prosthesis is lower limb prosthesis (John, 2005). The main problem in the design of above knee prosthesis is compatibility between the size of the stump and the socket. This is especially necessary at the time used to walk so it can function properly and users feel comfortable (Marc, 2005).

Gait analysis is a pattern of activities to observe the way for patients who use the prosthesis, aiming to obtain information relating to balance, comfort, ease of use and possible abnormalities experienced by these patients during normal walking and walking using a prosthesis (Rangdall, 2000, Farahmand, 2006).

There are two main parts in one cycle of walking, Phase Stance and Swing Phase. If one assumes when walking starts from the stepping right foot first, then the stance phase consists of: right initial contact, right midstance, terminal stance right, right preswing, then continued the swing phase consists of the right initial swing, right midswing, right terminal swing.

Important parameters are usually a concern at the time the gait analysis includes: walking speed, step/min = cadence, step time, step length, stride length, walking length total per minute, energy consumption is required and abnormalities that may be experienced by respondents (Rangdall, 2000). In this study, has produced five prototype with a socket prosthesis made of ramie fiber epoxy (RE) as the main material in this study, and as a comparative data socket is made from ramie polyester (RP) and fiberglass polyester (FGP). The five prototype prosthesis was made with anthropometric data that have been taken directly from the respondent. The process of making customized prosthesis with the method is that all sizes, data, and the fabrication process only for the patients concerned.

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This study aimed to perform gait analysis and determine the level of comfort that is felt by respondents to the prosthesis made.

Fig. 1. Gait Cycle (Rangdall, 2000) Fig 2. Step Terminology (Verne, 1981) Methods

Materials In this study developed a socket prosthesis with ramie fiber epoxy material (RE), where the

prototype made of Prototype I, Prototype Prototype II and III. While a comparison of data created with the socket prosthesis made from ramie fiber polyester (RP) with a Prototype IV and fiberglass polyester (FGP) with a Prototype V. Therefore gait analysis of prosthesis users a way I, II, III, IV data will be compared with test results of prototype V made of fiberglass polyester which has been used by several hospitals in Indonesia.

Table 1. Prototype Prosthesis Data (Agustinus, 2010)

Bahan Socket Prototype I Explanation

Ramie Epoxy (RE) Socket Weight 402 g Prosthesis Weight 3100 g Fabrication Methods Filament Winding Prototype II Socket Weight 405 g Prosthesis Weight 3110 g Fabrication Methods Filament Winding Prototype III Socket Weight 404.5 g Prosthesis Weight 3105 g Fabrication Methods Filament Winding

Ramie Polyester (RP) Prototype IV Socket Weight 487 g Prosthesis Weight 3500 g Fabrication Methods Mat

Fiberglass Polyester (FGP) Prototype V Socket Weight 588 g Prosthesis Weight 3700 g Fabrication Methods Mat

Methods

Gait analysis was done by using a prototype of the prosthesis by the respondents (patients) in turn. The use by respondents conducted starting in October 2009 and for each prosthesis used alternately for two weeks. Respondents use a prosthesis to work, Monday - Friday and sometimes required to work overtime on Saturday. Working hours from 07.00 - 17.00 WIB, bringing the total prosthesis usage time each day approximately 12 hours.

One phase of the gait analysis conducted for 6 minutes, patients to normal walking, in a quiet and flat road, so that disturbances from the environment can be ignored (Marc, 2005, Vincent,

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2008). Perform data processing of gait analysis in accordance with the gait parameters based on Gait Analysis Parameters Report, Physical Medicine & Rehabilitation by Randall L. Braddom, 2000.

The expected result is the development of socket prosthesis with the RE material was significantly defferent and better when compared with FGP material. Results and discussion

Gait analysis results that have been carried out in the table below: Table 2. Gait Analysis Result (Agustinus, 2010) No Gait Parameters I II III IV V

1 Steps total per 6 minute 509 508 507 497 492 2 Cadence (steps/min) 85 85 84 83 82 3 Step Time (s) 0.71 0.71 0.71 0.72 0.73 4 Right step length (cm) 41 41 41 41 41 5 Left step length (cm) 44 44 44 44 44 6 Step Width (cm) 20 20 20 20 20 7 Stride length (cm) 85 85 86 85 85 8 Stride total per 6 minute 255 254 253 248 246 9 Walking length total per 6 minute (m) 217 217 217 211 209 10 Walking length total per minute (m) 36.1 36.1 36.1 35.1 34.8 11 Walking Speed (m/s) 0.602 0.602 0.602 0.586 0.580

Walking speed

The purpose of this study was to produce a socket prosthesis with a natural fiber material (ramie fiber epoxy, RE) as alternative materials of polyester fiberglass socket (FGP). Therefore as comparative data for the walking speed data used Prototype V with FGP. Test values used for the test statistic is: 0, 580 m/s (walking speed of Prototype V).

Table 3. Walking Speed (m/s) (Agustinus, 2010)

Gait Parameter Prototype I Prototype II Prototype III Prototype IV Prototype V Walking Speed (m/s) 0.602 ± 0.005 0.602 ± 0.012 0.602 ± 0.006 0.586 ± 0.010 0.580 ± 0.005

Based on gait analysis data and statistical analysis was conducted with a prototype prosthesis above, it can be concluded that the prototype prosthesis I, II and III are made with ramie fiber epoxy (RE) material, can be used successfully with better speed and significantly different (p <0.05) with Prototype V. The results indicate that the Prototype I, II, III, with sockets from RE materials to produce a better walking speed when compared with the Prototype V with FGP socket material. Some results of other studies as a comparator associated with walking speed, among others: Tommy (1993) walking speed range for men with age 30-39 years with normal walking ranges between (0,486 – 1,28) m/s. Farahmand (2006), walking speed in m/s resulting from these studies with the walking speed 0,668 ± 0,196 m/s. This value is entered in the range of research results, Tommy (1993). If referring to the study, the Prototype I, II, III produces good walking speed and can be developed further. Cadence (step/min)

In the gait analysis, the number of steps that can be generated by the respondent always considered and counted as one of the criteria in concluding whether the prosthesis can be used well or not. In general, various books and journals mentioned that the number of steps per minute on a normal walking values obtained varied between (70–90) steps per min. In the range of these steps, users can be said prosthesis to walk comfortably and normally. For the medium speed group: 95 steps per minute and high-speed group is 120 steps per minute (Signe, 1983). While Verne (1981), suggest that the number of steps per minute when walking is between (70-130) steps per min.

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Table 4. Cadence (Step/min) (Agustinus, 2010)

Gait Parameter Prototype I Prototype II Prototype III Prototype IV Prototype V Step/min 85 ± 0.28 85 ± 0.69 84 ± 0.67 83 ± 0.67 82 ± 0.32

Based on the results of statistical analysis has been carried out on Prototype I, II, III and IV

compared with the Prototype V as above, it can be concluded that the Prototype I, II and III are made with ramie fiber epoxy material (RE), resulting in a number of steps per minute more when compared with the Prototype V and differed significantly (p < 0.05). Thus Prototype I, II, III, better than the Prototype V as a reference in a number of steps per minute that can be generated.

Fig. 3. Step Length Measurement (Agustinus, 2010)

Walking length per minute

The next criteria that can be used to assess whether the resulting prosthesis can be used well by the respondent is the walking length total per minute. The further the distance walked per minute, indicating that the prosthesis comfortable to use, so that respondents can use the prosthesis for walking is easy and light. Table 5. Walking Length Total Per Minute (Agustinus, 2010)

Gait Parameter Prototype I Prototype II Prototype III Prototype IV Prototype V Walking Length Total per

min. 36.1 ± 0.28 36.1 ± 0.75 36.1 ± 0.34 35.1 ± 0.59 34.8 ± 0.28

Based on the results of statistical analysis was conducted with a prototype prosthesis above, it

can be concluded that the Prototype I, II and III (made from RE material have a longer length walking with significant differences (p <0.05) when compared Prototype V with a reference made in this study. These results indicate that the prosthesis with the socket of the RE materials more easily, lightweight, comfortable to use with walking length per minute longer than FGP material. Step time The process of walking is also determined by how long it takes to produce a single step. In the gait analysis prosthesis user, the data required to perform one step has been obtained for each prosthesis prototype made and tested. Based on the results of statistical tests that have been made to the prototype prosthesis above, it can be concluded that the Prototype I, II and III are made of ramie fiber epoxy material (RE) yields the average time per one step faster than Prototype V with a difference significant (p <0.05). These results indicate that the Prototype I, II, and III can be used by the respondents with the time per one step faster than the Prototype V.

Respondent

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Table 6. Step Time (Agustinus, 2010)

Gait Parameter Prototype I Prototype II Prototype III Prototype IV Prototype V Step Time 0.71 ± 0.002 0.71 ± 0.01 0.71 ± 0.01 0.72 ± 0.01 0.73 ± 0.003

Physiological criteria

One method to measure the fatigue level from an activity carried out by someone, for example, when walking using prosthesis is the use of physiological criteria to measure heart rate per minute before and after analysis of the gait analysis.

Table 7. Heart Rate (pulses/min) (Grandjean, 1993)

No Assessment of Work Load Heart Rate (pulses/min) 1. Very low (resting) 60 – 70 2. Low 75 – 100 3. Moderate 100 – 125 4. High 125 – 150 5. Very high 150 – 175 6. Extremely high (eq. Sport) > 175

According to Grandjean (1993), the burden of an activity can be measured using heart rate

while doing the activity. Heart rate can also be used to estimate the physical condition or degree of physical fitness person and measure fatigue resulting from an activity carried out.

Based on the results of gait analysis has been carried out on the road to five prototype prosthesis, heart rate data obtained were measured using pulsemeter before and after analyzing presented in the following table. Heart rate data acquisition each prototype as many as 15 times.

Based on measurement and analysis has been done shows that for all pairs of data per minute heart rate before and after analysis of the gait analysis of the five prototype prosthesis there was significant difference (p <0.05) heart rate before and after gait analysis. This indicates that the activities by using the prosthesis, the respondents require a certain amount of energy that is indicated by increased heart rate per minute.

Table 8. Heart Rate (pulses/min) Before and After Gait Analysis (Agustinus, 2010)

Prototype Explanation Avg (pulses/min) SD

I

Before 86 0.80 After 89 0.90

Deviation 3 0.10 II

Before 83 0.51 After 85 0.62

Deviation 3 0.11 III

Before 84 0.82 After 86 0.76

Deviation 2 0.06 IV

Before 86 0.83 After 90 0.64

Deviation 4 0.19 V

Before 85 0.74 After 90 0.96

Deviation 4 0.22

From Table 9 showed that prosthesis prototype which is lighter, resulting in excess heart rate

before and after gait analysis of smaller. There was a positive correlation between the weight of the prosthesis with the energy needs at walking time by using the prosthesis. The more light the more comfortable prosthesis characterized by a smaller difference between heart rate before and after analysis of gait analysis use the prosthesis.

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Table 9. Summary of Differences pulse Heart Pattern Analysis Road (Agustinus, 2010) No. Prototype Deviation (pulses/min) 1 Prototype I 3 ± 0.10 2 Prototype II 3 ± 0.11 3 Prototype III 2 ± 0.06 4 Prototype IV 4 ± 0.19 5 Prototype V 4 ± 0.22

If the data were analyzed by using Table 7, was walking with a prosthesis as has been done in

the gait analysis, including in the work category with light to moderate activity with a range of heart rate between 75-100 pulses per minute for the condition of healthy people. Respondent's heartbeat during the process of analyzing the lowest 82 pulses per minute and as high as 92 pulses per minute. Thus we can conclude that the patient reasonably comfortable while using a prototype prosthesis for walking. Psychophysical criteria

Psychophysical criteria measurement using questionnaires, given to the respondents for using a prototype prosthesis. Filling in this questionnaire will produce the subjective opinions of respondents who researched, which involves a matter of convenience and perceived grievances in doing an activity. The results of this questionnaire can be used to evaluate a product design is ergonomic criteria according to the user or not [10,12,13].

The walking comfort using a prototype prosthesis subjectively by the research respondents, obtained by filling out the questionnaire in accordance with the convenience of gait analysis has been done. The answer was classified into five categories: Score 1: Less so, 2: Less, 3: Moderate, 4: Good, 5: Very Good. As a test value was taken comfort in the value of 3.

According to analysis it can be concluded that according to respondents, the prototype prosthesis who fall into convenient groups (value> 3) is the prototype I and II. Prototype III is among the comfortable and moderate (average value: 2.8), while Prototype IV and V according to the respondents are not comfortable (score < 2.5). Thus Prototype I, II and III is the prototype of the most convenient according to the respondents compared with Prototype IV and V. Prototype I, II and III have a socket component materials made from ramie epoxy.

If explored, the difference in weight of each prosthesis as in Table 1, it can be concluded that the more weight prosthesis, then the walking speed that can be done also decline. This may occur because of increasingly weight prosthesis that is used, then the energy required to lift and move will be higher, so the impact on walking speed reduction that can be done.

Weight prosthesis also has an effect on the number of steps per minute (cadence), which can be generated by the respondents. Statistical analysis of the number of steps per minute which can be generated by the respondents indicated that there were significant differences between the number of minute steps that can be generated by the Prototype I, II and III with Prototype IV and V, to the reference value of 82 steps per minute (p < 0:05). Thus we can conclude that based on the analysis refers to the value of the reference hypothesis (Prototype V), Prototype I, II and III is more convenient to use when compared with the Prototype IV and V. Thus, the socket prosthesis made from RE materials more comfortable than the socket prosthesis made from RP and FGP materials.

As selected ramie fiber composite materials used in this study to consider the potential of ramie fiber in Indonesia's abundant and untapped well. This is in line with the issues concerning the environment, which is currently developing a new view on the go green and back to nature. Natural fibers (like ramie fiber) are very potential to be developed and fulfill the criteria for the use of natural materials. if observed from the ratio of strength, the results of research that has been published by the researchers showed that the ramie fibers have a good ratio of strength and light weight, so according requirement in the development of socket prosthesis.

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Fig. 4. Walking Speed vs Weight Socket Comparison Chart (Agustinus, 2010) Conclusion

Based on the gait analysis that has been done, it can be concluded that the Prototype I, II and III have a good comfort level compared to the Prototype IV and V. Prototype I, II, and III is a prototype socket prosthesis made using ramie fiber composite material. Ramie fiber is a natural fiber which is Indonesia's natural wealth, the potential for abundant, environmentally friendly and not yet widely utilized. Socket produced lighter, stronger and more flexible, thus greatly affect the comfort level felt by the respondents.

Prosthesis comfort during use is a function of anthropometry, weight, strength, flexibility, and surface roughness of the socket prosthesis. These variables can be met by the prototype socket prosthesis made from RE composite material. Respondents perceived the real comfort is subjective according to the feelings and psychological situation of the respondents themselves. This indicator is used only functions as a tool and the final determinant of a respondent's own convenience. References Agustinus Purna Irawan, Tresna P. Soemardi, Widjajalaksmi K, Agus H.S. Reksoprodjo (2010) Buku penelitian III.

Departemen Teknik Mesin, Universitas Indonesia. Bridger, R.S. (1995) Introduction to ergonomics, International Ed., McGraw Hill. BS ISO 10328-3 (1996) Prosthetics, structural testing of lower-limb prostheses, principal structural tests, www.iso.org. F. Farahmand, T. Rezaeian, R. Narimani, P. Hejazi Dinan (2006) Kinematic and dynamic analysis of the gait cycle of above-

knee amputees, Scientia Iranica. 13, 3:261 – 271. Grandjean, Etienne (1993) Fitting the task to the man, a text book of occupational ergonomic, 4th Editions, Taylor & Francis

Ltd, London John Craig (2005) Prosthetic feet for low-income countries, JPO, 17, 4S:27 – 49. Julie D. Ries, John L. Echternach, Leah Nof, Michelle Gagnon Blodgett (2009), Test Retest Reliability and Minimal

Detectable Change Scores for the Timed “up & Go” Test, the Six Minute Walk Test, and Gait Speed in People with Alzheimer Disease, Physical Therapy, 89, 6:569 – 579.

Marc Kosak, Teresa Smith (2005) Comparison of the 2-, 6-, and 12-minute walk test in patients with stroke, JRRD, 42, 1: 103-108.

Rangdall L. Braddom, (2000) Physical medicine & rehabilitation, Second Edition. W.B. Saunders Company, Philadelphia. Sander Mark S., McCormick Ernest J. (1992) Human dimension and in engineering and design, 7th Editions, McGraw-Hill

Inc Singapore. Signe Brunnstrom (1983) Clinical kinesiology, Edition 4. F.A. Davis Company, Philadelphia. Singgih Santoso (1999), SPSS mengolah data statistik secara profesional, Elek Media Komputindo, Jakarta. T.A. Current, G.F. Kogler, D.G. Barth (1999) Static structural testing of transtibial composite sockets, Prosthetics and

Orthotics International, 23:113-122. Tommy Oberg, Alek Karsznia, Kurt Oberg (1993) Basic gait parameter: reference data for normal subject, 10 – 79 years of

age, JRRD, 30, 2:210 – 223. Verne T. Inman, Henry J. Ralston, Frank Todd (1981) Human walking. Williams & Wilkins. Vincent Gremeaux, Marwan Iskandar, Gaelle Kervio, Dominic Perennou, Jean Marie Casillas (2008) Comparative analysis

of oxygen uptake in elderly subjects performing two walk tests : the six minute walk test and the 200-m fast walk test, Clinical Rehabilitation, 22:162 – 168.

3.100 3.110 3.105

3.5003.700

0.5880.4870.4050.402 0.405

0.5800.5860.6020.6020.602

0.000

0.500

1.000

1.500

2.000

2.500

3.000

3.500

4.000

Prototype I Prototype II Prototype III Prototype IV Prototype V

Socket Weight (kg) Prosthesis Weight (kg) Walking Speed (m/s)