Walking Aids

Musmate, P. O. Box 3976, Bath BA1 0DF, UK Tel. (0845) 094 4674; fax (0845) 094 4674; e-mail sales@musmate.co.uk .

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Clinical Results for the Musmate Walking Aid 1. Introduction This section sets out the medical information about the Musmate Walking Aids. The first section contains a more technical description of the product and its function, including warnings and contra-indications. The second section discusses the test results demonstrating the effectiveness of the Musmate Walking Aid. 2. Product Information 2.1 Product Description and Usage The Musmate Walking Aid is an innovative new product which is intended to assist people with foot drop (lack of ankle dorsiflexion) The product consists of a shoulder harness which is connected to the foot with an elastic cord assembly and a shoe connecting accessory. Optional shoulder pads and waist belts are provided. When the foot is lowered to the ground during the gait cycle, the elastic cord is stretched. Upon lifting the leg, the shoulders support the lifting of the foot as the cord contracts and this action improves the patient’s walking gait. Use of the Musmate usually leads to increased walking speed, which is indicative (see later) of better gait and ability to walk further. Other benefits may include preventing disuse atrophy, and improved muscle strength. Its use reduces the incidence of trips or falls, and eliminates the foot-dragging. There are slightly different products provided for children and adults. Drop foot can arise from many conditions, included stroke, multiple sclerosis, spinal injury, motor neurone disease, and certain genetic diseases. 2.2 Adverse Effects May cause leg, shoulder, and/ or back pain due to increased muscle usage. This should fade as the muscles strengthen. If the knee muscles have not been used for a long time, then knee pain has been reported. There has been one report of pins and needles in the feet following use. 2.3 Contraindications The Musmate places additional strain on the back and so those people with weak backs (eg from arthritis of the spine) should not use the Musmate except under clinical supervision. It supports walking and so those who are unable to walk 10 metres (with aids such as walking sticks) are unlikely to benefit. 2.4 Cautions The Musmate cannot be used with some shoes such as high heels, shoes cut low at the front, or those which expose the person’s heel (eg clogs). The Musmate can be worn underneath clothes, but this may be less comfortable, and the Musmate is more difficult to adjust. The Musmate shoe harness can cause scuffing and wear to shoes and/ or shoelaces.

3. Research Results

Objective
To assess the clinical effectiveness of the Musmate Walking Aid by analysis of its impact on the speed of walking. This orthosis uses an elastic cord to support the lifting of feet in those people who suffer from lack of ankle dorsiflexion (foot drop).

Design
A study of sixteen people who used the Musmate over a period of one month.

Subjects
Sixteen people living with multiple sclerosis who had developed foot drop.

Setting
A charitable therapy centre which provides a number of treatments including high density oxygen treatment (HDOT) and physiotherapy to people with multiple sclerosis.

Main Outcome Measure
Changes in walking speed over a ten-metre course.

Results
When the test started, the mean walking speed of the group was 0.44ms^-1, which rose to 0.64ms^-1 when the Musmate was initially fitted. The T-Test result was 6.194 with a 2-tailed significance of 0.000. After one month, the walking speed without the Musmate had increased to a mean 0.57ms^-1 (T-test 3.371, significance 0.003) and with the Musmate to 0.73ms^-1 (T-test 2.828, significance 0.013). Comparison of the initial walking speed without the Musmate and the final speed with it, yielded a difference of 0.29 ms^-1 (T-test 5.795, significance 0.000) .

Conclusions
This report discussed the development of a new medical device which enables people with multiple sclerosis to walk more effectively. The test results showed that the mean walking performance of the people using it, as measured by the ten-metre walk, was improved by 67% on average after one month. Since the unaided walking speed also saw a noticeable improvement, it is postulated that the combination of the additional effort required to stretch the elastic cord, the ease of walking with the Musmate Walking Aid, and the increased confidence in their own walking ability has resulted in much more exercise than previously, and this has strengthened the leg muscles.

Some minor side-effects of use were reported- particularly muscle pain arising from the more intensive use of muscles. This did decline in time for all participants. However, all participants in the trial responded very well to the product.

Introduction
Multiple sclerosis¹ is a disease which affects approximately 2,000,000 people² worldwide, of which the majority are women³. There are many symptoms¹ of this disease, but one common one (around 40%⁴ of all cases) is that nerve damage leads to problems in moving limbs, particularly one or both of the legs. This leads to lack of ankle dorsiflexion, commonly known as foot drop.

Foot drop has a number of consequences. Firstly, walking becomes much more difficult⁵ since the foot is not lifted, but has to be dragged along or thrown to the side. Secondly footwear can get badly damaged if the side and top of the shoe are dragged along the ground and quickly become scuffed and worn. This severely restricts both the speed and distance that such people can walk. Finally, balance is much more difficult since the weakened leg(s) can no longer be relied upon.

The lack of mobility not only impinges on their health, but is a serious social problem, since it can prevent them from working and leads to social isolation. In addition, further medical problems are related to the lack of exercise, particularly breathing problems⁶, spasticity,^7,8 and muscle-wasting⁹. The problems are not only with the mechanics of walking, but also in the psychology, since one study¹⁰ found that even when medically classified as “independent walkers” some people become much more housebound due to loss of confidence in their mobility.

Current, there are a range of treatment^11,12 options to assist these patients, including ankle-foot orthoses (AFO), silicone ankle-foot orthoses (SAFO), and functional electrical stimulation. However, all of these products have disadvantages and research indicated the need for a better, more-cost effective treatment option.

Consequently a new product, the Musmate Walking Aid, has been developed to improve the walking performance of people with foot drop. It consists of three components. The first is a shoe attachment (of which there are several designs), a shoulder harness, and an adjustable elasticated cord. This is fitted so that when the leg muscles are relaxed, the effort of lifting the leg is partly borne by the shoulder harness, by transmission through the elasticated cord assembly. There are different designs for those with problems with either or both legs.

An important additional feature is the Musmate’s adjustability. The strength of the lift can be adjusted easily to meet the needs of the wearer. Furthermore, the height of the lift of the foot can be independently increased to enable people to climb stairs, go uphill, or to cross rough terrain. The product is designed to be readily fitted by the wearer with no expert input.

Methods
Patient Selection
The sixteen people selected for the trial were all regular users of the local charitable therapy centre. They were all able to walk for ten metres, using only walking sticks as aids if required.

Assessment
Current clinical assessment practice¹⁰ is to use the walking speed over a ten metre course as a good clinical indicator of overall gait function. The people were asked to walk over a measured ten-metre course at their normal walking speed whilst they were timed. This was done twice, once whilst wearing the Musmate, and once without. The order of the two walks was randomised. This was repeated after one month to see what effect it had.

Since this device is actively supporting the leg movement, no blinding of the trial is possible since a user would be aware whether a device was active or not. It is known that the walking performance of people with multiple sclerosis does not improve spontaneously (although it may not decline either) and so it is reasonable to assign any improvement in performance to the use of the device.

Analysis
The mean test results for the work are shown in Figure 1. These were statistically analysed using the T-Test and the results are shown in Table 1. When the user is first fitted with a Musmate, their walking speed increases by a mean 45% (T 6.194, significance 0.000). After one month, their walking without a Musmate had climbed by 27% (T 3.371, significance 0.004). Since the walking aid is not being used in these tests, the increase has to be due to improvement in walking and/ or fitness of the user resulting from the easier walking when using the Musmate. The impact of walking with the Musmate is less significant. After one month, when walking with the Musmate, the increase was 14% (T 2.828, significance 0.013). When walking with the Musmate after one month is compared with the original walking without it (i.e. the overall walking benefit), the improvement is 67% (T 5.795, significance 0.000), showing just how much impact the Musmate makes on walking. However, this work would undoubtedly benefit from a larger population being studied over a longer timeframe, and this will be pursued.

Verbal feedback from the volunteers was very positive. They noted that the device enabled them to become much more mobile and active than they were previously. This improves their overall health and social wellbeing. For example, in one case the product improved the person’s mobility so much that they were able to return to work. In some cases, the volunteers noted that the device improved their outlook- the progressive phase of the disease was viewed as being less serious because the decline in physical deterioration was slowed.

Any product will have disadvantages, and the following comments were made by the recruited people. There were many aches and pains, particularly in the feet, legs, and back, when the product was used initially. It is postulated that this is due to the muscles working harder than previously. This is true not only for the foot and leg muscles, but also those of the back, which has to support the additional work of the shock cord in raising the leg. However, these short term effects soon wear off as the muscles strengthen in response to the additional demands placed on them.

Conclusions
This report discussed the development of a new medical device which enables people with multiple sclerosis to walk more effectively. The test results showed that the mean walking performance of the people using it, as measured by the ten-metre walk, was improved by 67% on average after one month. Since the unaided walking speed also saw a noticeable improvement, it is postulated that the combination of the ease of walking and increased confidence has resulted in much more exercise than previously, and this has strengthened the leg muscles.

Some minor side-effects of use were reported- particularly muscle pain arising from the more intensive use of muscles. This did decline in time for all participants. However, all participants in the trial responded very well to the product.

Table 1. The T-Test Results for the Changes

Figure 1. The Change in Walking Speed During the Test

References
1. McAlpine’s Multiple Sclerosis, Matthews W B, Churchill Livingstone, UK, 1991
2. From Multiple Sclerosis Society website, http://www.mssociety.org.uk
3. Acheson E D, ‘Epidemiology of Multiple Sclerosis’, British Medical Bulletin, 1977, 33, 9-14
4. Kurtze J F, ‘Clinical Features of Multiple Sclerosis’ in Vinken P J, Bruyn G W (eds) Handbook of Clinical Neurology, 1970, 9, Norton Holland, Amsterdam, p161-216
5. Olgiati R, Jacquet J, Di Prampero P E, Energy Cost of Walking & Exertional Dyspnea in Multiple Sclerosis’, American Review of Respiratory Disease, 1986, 134, 1005-1010
6. Smeltzer S C, Ulell M J, Rudick R A, ‘Pulmonary Function & Dysfunction in Multiple Sclerosis’, Archives of Neurology, 1988, 45, 1245-9
7. Dimitrijevic M R, Nathan P W, ‘Studies of Spasticity in Man: 1. Some Features of Spasticity’, Brain, 1967, 90, 1-30
8. Dimitrijevic M R, Nathan P W, ‘Studies of Spasticity in Man 2. Analysis of Stretch Reflexes in Spasticity’, Brain, 1967, 90, 333-358
9. Davison C, Goodhart S P, Lander J, ‘Multiple Sclerosis & Amystrophies’, Archives of Neurology & Psychiatry (Chicago), 1934, 31, 270-289.
10. Wade D, Wood V, Hellar A, Maggs J, Langton-Hewer R, ‘Walking after stroke’, Scandinavian Journal of Rehabilitation Medicine, 1987, 19(1), 25-30
11. Liversedge L A, ‘Treatment and Management of Multiple Sclerosis’, British Medical Bulletin, 1977, 78-83
12. Russell W R, Multiple Sclerosis: Control of the Disease, Pergamon Press, Oxford, 1976

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