Clinical Results for the Musmate Walking Aid for Foot Drop

1. Research Results

People with multiple sclerosis (MS) commonly have walking problems due to nerve damage affecting both muscles and balance. 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 problems, spasticity, and muscle-wasting. The problems are not only with the mechanics of walking, but also in the psychology, since one study found that even when medically classified as “independent walkers” some people become much more housebound due to loss of confidence in their mobility.

Objective
To assess the clinical effectiveness of the Musmate Walking Aid for Foot Drop by monitoring its effectiveness on a group of people with foot drop.

Introduction
A new product, the Musmate Walking Aid for Foot Drop, has been developed to improve the walking performance of people with foot drop. It consists of three components. The first is a shoe attachment (either a shoe harness for shoes or a shoelace connector for shoelaces or sandal straps), 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 multiple sclerosis therapy centre. They were all able to walk for eleven yards, using only walking sticks as aids if required.

Assessment
Current clinical assessment practice is to use the walking speed over an eleven yard (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.

Results
When the test started, the mean walking speed of the group was 0.98 mph, which rose to 1.43 mph when the Musmate was initially fitted. The T-Test result was 6.194 with a 2-tailed significance of 0.000 indicating that this difference is very significant. After one month, the walking speed without the Musmate had increased to an average (mean) 1.28 mph (T-test 3.371, significance 0.003) and with the Musmate to 1.63 mph (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 0.65 mph (T-test 5.795, significance 0.000) . All these differences are statistically very significant. The mean test results for the work are shown in Figure 1.

Figure 1. The Change in Walking Speed During the Test

The test was continued for three months but during this time, a number of people left the test. Nine people completed all three months. Their walking was measured every month, and the results are shown in Figure 2. The difference between walking with and without the Musmate is very statistically significant at every data point and in addition, the difference between walking without the Musmate at the start and end of the test is statistically significant. Furthermore the difference between walking with the Musmate at the start and end of the three month period is also statistically significant.

Figure 2. The Mean Walking Speed over Three Months

Conclusions
The test results showed that the mean walking performance of the people using it, as measured by the eleven yard (ten metres) 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 Foot Drop 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.

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.

Clinical Results for the Musmate Walking Aid for Foot Drop

Product Information

The Musmate Walking Aid for Foot Drop Aid is assists people with foot drop (lack of ankle dorsiflexion), poor knee flexion, and/ or poor hip flexion. The product consists of a shoulder harness which is connected to the foot with an elastic cord assembly and either a shoelace connector or shoe harness. 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. Not only is ankle dorsiflexion supported, knee flexion and hip flexion are also made easier by the Musmate. The elastic cord pulls the foot up, and because the foot knee and hip ar enot in one line, the effect is to encourage the knee to bend. The pull of the cord (which ultimately attaches to the shoulder) takes some weight off the hip and so swinging the leg forward is easier.

Other benefits may include preventing disuse atrophy - muscles decay when they are not used- of the ankle dorsiflexor muscles, 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.

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.

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 without medical support. 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.