For Physicians and Medical Retailers Information for patients can be found here.

Study on the functional effectiveness of MalleoTrain Prospective effectiveness

Issue 01/2020

Researchers are very interested in the ankle: how effective can the MalleoTrain support be during ankle treatment? A study carried out by the Technical University and Chemnitz Hospital , Germany, seeks to provide answers. One answer has already been returned: prospective effectiveness.

Scientists responsible for the Chemnitz study (from the left): Dr. med. Ludwig Schütz, Dr. med. Anica Kilper, Laura Niklaus and Prof. Dr. Thomas Milani.
Scientists responsible for the Chemnitz study (from the left): Dr. med. Ludwig Schütz, Dr. med. Anica Kilper, Laura Niklaus and Prof. Dr. Thomas Milani.

Ligament injuries in the upper ankle account for a third of all traumas, sprains being the most common injury altogether. If the goal is to prevent chronic instabilities and possible subsequent damage such as osteoarthritis, the diagnostic and therapeutic focus must be on the joint’s function. In order to examine the effectiveness of the MalleoTrain support as part of conservative treatment regimen, an extensive study is being conducted in Chemnitz. Research partners include the Movement Science Professorship of the Technical University (TU), led by Prof. Dr. Thomas Milani, as well as the Department of Orthopedics, Trauma and Hand Surgery at Chemnitz Hospital with the Head of the Department , Physician Dr. med. Ludwig Schütz. “Injuries in the area of the foot are often underestimated,” emphasizes Dr. Schütz. “High case numbers and prolonged disease states highlight the importance of the examination.” Prof. Milani summarizes the contents: “Proving the effectiveness of the support is central to the study. At the same time, we’re interested to see how the body responds to the supportive effect. This is a very complex issue, which also includes proprioceptive and sensorimotor factors.”

Sarah Heidinger from TU Chemnitz demonstrates the modified Y Test with MalleoTrain. The test makes maximum demands on the test subjects’ functional stability.

Is functional stability affected?

In order to examine all aspects, several examination procedures are combined and analyzed. One of the most powerful tests for functional stability is the Y Balance Test. The test subject stands on the leg with the injured ankle and tries to lift the other leg as far as possible: to the front , back and out , back and in. This test makes maximum demands on strength, stability, mobility, balance and coordination. “Therefore, the deficit in performance that can be measured is proportionately high, as soon as one parameter is affected,” Laura Niklaus, TU Study Director, explains (see interview): “The Y Test is used very often in therapy because of its simplicity and complex profile of requirements on the patient. It has gained in scientific popularity in recent years.”

Measuring the hindfoot angle with inertial sensors

Part of the study design is the center of pressure (CoP) when standing on one leg: patterns of strain are measured via a pressure plate for two periods of twenty seconds. “The CoP is the key parameter for the evaluation of balance in movement science,” Laura Niklaus explains. Gait analysis is also revealing for the researchers. Previously, VICON, a laboratory-based camera system for the important measurement of the hindfoot angle and the hindfoot movement , was the standard. “As of late, inertial sensors are increasingly being used during scientific evaluations because they can be utilized freely,” the study director says. “We’re also embracing this procedure.” Inertial sensors on the heel are useful because they show up asymmetries which make the gait less harmonious and therefore more unstable.

The joint angle reproduction test provides information about fine coordination.
The joint angle reproduction test provides information about fine coordination.

Unique joint angle reproduction test

Another special feature of the Chemnitz examination method is the use of the joint angle reproduction test. This test is mainly used after cruciate ligament injuries to illustrate the potentially restricted proprioceptive performance of the knee. TU’s movement scientists have modified the joint angle reproduction test in such a way that it can also be used for the sensorimotor function of the ankle – with a unique assembly: the foot is freely placed on a rocker board. The smallest movements in the ankle then lead to slight pronation and supination of the foot. The test subject is requested to trace as precisely as possible a changing line on the screen using these fine tilting motions. This experiment is designed to show whether the spatial sense of position, a proprioceptive skill , provides correct instructions for the motor function.

During the medical screening examination, Dr. med. Anica Kilper checks the talar shift with the ventral drawer test.
During the medical screening examination, Dr. med. Anica Kilper checks the talar shift with the ventral drawer test.

Ankle treatment is inadequate in many cases

In order to answer questions about balance, fine coordination and, in the end, stability, additional series of measurements are required by Laura Niklaus and the masters candidates Sarah Heidinger, Dennis Kaiser and Timo Lenders, who are analyzing the acute effects of MalleoTrain on gait and balance as well as long-term effects on balance in their theses. The test subjects’ subjective assessments relating to their sense of stability, pain perception and comfort when wearing the support are also included in the final evaluation. First of all , however, the investigator, Dr. med. Anica Kilper from the Department of Orthopedics, Trauma and Hand Surgery, needs to create the right conditions. After initial treatment of the potential test subjects in the hospital’s emergency department , she performs detailed examinations, such as joint lift-off or talar shift , to check whether the eligibility criteria are met. The crucial aspect is ‘acute initial supination’. This reflects the basic problem in the foot , according to the physician: “Only one in ten patients with supination injuries fulfills the criterion ‘acute initial injury’. All others are either chronically unstable, have a recurring injury or have sprained their ankle once or several times a long time ago. This shows us that ankle treatment is inadequate in many cases.”

A better sense of balance with MalleoTrain

One thing is already beginning to show in the Chemnitz study: “Almost all test subjects are reporting that their subjective sense of balance is better with MalleoTrain than without ,” Laura Niklaus says. “This is promising because, with a subjectively positive feeling, patients will gain in confidence, get active and start using their foot again. That’s incredibly important!” This means one hypothesis for the result of the study can be proposed even now: prospective effectiveness.

Study details: Using MalleoTrain following initial supination trauma

Test subjects: n = 60; 30 with MalleoTrain, 30 w/o MalleoTrain

Design: prospective, controlled, randomized

Measurement process: Experimental and clinical data will be established at V1 and V2:
V1: 5 weeks post-traumatic (after wearing an orthosis in accordance with DGU guidelines)
V2: 7 weeks post-traumatic, after two weeks of wearing the support

Inclusion criteria: Initial diagnosis: dislocation of the upper ankle or lesion of the lateral collateral ligament ,
acute trauma, no older than three days

Exclusion criteria: Ankle fractures, previous ankle trauma within less than one year and/or chronic ankle instability

Test methods:
Gait analysis: Plantar pressure distribution during walking at the test subject’s chosen speed,
measurement of hindfoot movement with inertial sensors
Balance tests: Y Balance Test , Center of Pressure (CoP)
Joint angle reproduction test
Questionnaires for subjective self-assessment: Foot Function Index (FFI), Visual Analog Scale (VAS),
evaluation sheet created for the study

Images: Frank Steinhorst


Articles you could be interested in

Train supports for outdoor enthusiasts Physiotherapy, the Canadian way

Right on your doorstep: the Pacific – behind the house: the Coast Mountains Nathan Vanderkuip, physiotherapist from Vancouver, enjoys letting his …

Train supports in sports physiotherapy Numbers don’t lie

Treating patients is one thing; conducting research and incorporating research results into physiotherapy techniques is something completely …

New insights into MalleoTrain “How can we measure stability?”

Study Director, Laura Niklaus from TU Chemnitz, is a scientist and sports therapist , meaning she combines theory and practice. The perfect …