PDF Orthopädietechnische Indikationen (German Edition)

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People with a paresis or paralysis of the knee extensors depend on knee-ankle-foot orthoses KAFOs to restore walking ability. Unlike locked KAFOs whose orthotic knee joints are only unlocked for sitting down, stance control orthoses SCOs may utilize various mechanisms to lock the orthotic knee joint during the stance phase and unlock it for a free swing phase. Thus far, all studies comparing SCOs to locked KAFOs have only used laboratory-based measures, but no clinical performance measures commonly used in rehabilitation medicine. Therefore, the aim of this study was to investigate functional walking capacity using the 6-minute walk test 6MWT , combined with objective 3D gait measurements, in established SCO users when using the orthosis in the unlocked and locked mode, respectively.


A total of eight subjects participated in this study. The results show that in the locked condition, subjects walked a significantly shorter distance Compared to the unlocked condition, the locked mode imposed a clinically meaningful restriction to the functional walking capacity on the subjects.

Therefore, fitting of an SCO may be considered beneficial in individuals dependent on a KAFO to improve their functional walking capacity. In total or partial weakness of knee extensors, patients are usually fitted with a custom Knee Ankle Foot Orthoses KAFO , mostly with a manually locked knee joint that provides safety while walking and can be released for sitting down [].

Orthoses with locked knee joints locked KAFOs restore basic walking capabilities but have considerable biomechanical and clinical disadvantages compared to normal walking [].

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To avoid stumbles when walking, the patient usually uses hip hiking and sometimes even unnatural plantar flexion during mid-stance on the sound side vaulting to provide sufficient toe clearance during swing [7]. Although they provide the required safety by locking the knee joint for stance, they also enable free knee flexion during the swing phase. If the patient has sufficient residual function of the paretic leg to safely operate one of the available mechanisms to lock and unlock the orthotic knee joint, SCOs have clear known benefits over locked KAFOs.

These are greater toe clearance, more physiologic gait pattern, faster walking speed and lower metabolic energy expenditure. In addition, reduced compensatory movements may be observed. Because of these benefits, patient satisfaction may be increased [,]. Thus far, all studies comparing SCOs to locked KAFOs have only used laboratory-based measures such as 3D gait measurements, metabolic energy expenditure in treadmill walking, and electromyography assessments, but no clinical performance measures commonly used in rehabilitation medicine.

Therefore, the aim of this study was to investigate, for the first time to the best of our knowledge, functional walking capacity using the 6-minute walk test 6MWT , combined with objective 3D gait measurements, in established SCO users when using the orthosis in the unlocked and locked mode, respectively. This study was a randomized 2x2 crossover design study in which each patient served as his or her own control. The intervention was to perform the 6MWT and motion capture with the knee joint unlocked A and locked B in randomized order.

The order of the test conditions A-B or B-A was sealed in envelopes. All participants gave written informed consent to participate in this study. The study was approved by the ethics committee of the state medical council of Niedersachsen, Germany.

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Then they performed the 6MWT and the gait analysis with the SCO in locked and unlocked conditions with a rest period of two hours between the conditions. KGaA, Duderstadt, Germany [11] is an orthotic knee joint for custom orthoses providing a locked stance phase and free swing phase. As a requirement for using the functions of this SCO, the user must be able to fully extend the orthotic knee joint at the end of the swing phase to re-lock the orthosis for stance. During the entire stance phase, the orthosis remains locked. The knee automatically unlocks at terminal stance when an extension moment is acting on the knee and the thigh segment angle exceeds an adjustable, patient-specific angular threshold.

The lock and release mechanisms work independently from the ankle joint. The foot part is usually equipped with an orthotic ankle joint with a dorsal stop that produces a knee extension moment at terminal stance. Participants had to be at least 18 years old, have a maximal body weight of kg, had to have been using an SCO with the E-MAG Active for at least one year and be willing to participate in the study. Additionally, the users had to be able to walk a total of 20 minutes without a break with both the E-MAG Active in the locked and unlocked conditions.

Kinematic measurements were conducted by monitoring 21 retroreflective markers attached to the body according to a self-developed model described in a previous publication [13]. The QUEST asks for a rating of 12 satisfaction items, eight of which are related to the device, and the remaining four to the service around the device.

Each item is rated on a 5-point scale, with a score of 1 denoting "not satisfied at all" and 5 indicating that the person is "very satisfied". Additionally, the user was asked to select the three of these 12 satisfaction items that are the most important ones to him or her []. A total of eight subjects 3 female with an average age of The underlying etiologies were incomplete spinal cord injuries 4 patients , poliomyelitis 3 patients and myopathy 1 patient.

The right leg was the affected side in six subjects. The affected legs showed clearly weakened muscle strength in all subjects with the knee extensor strength not exceeding grade one in the manual muscle test. The demographic data is shown in Table 1. Patient- code [ ]. Results of the manual muscle testing on the affected leg The difference in the distance walked of The time-distance-parameters are shown in Table 2. The walking speed was significantly faster with the SCO in the unlocked mode.

Furthermore, gait symmetry was marginally improved. Table 2. Figure 1. Biomechanical parameters exemplified for one subject. A Knee flexion angle with the E-MAG in the locked mode; B Pelvic obliquity; C Contralateral vaulting, shown with the sagittal angle of the ankle above and the sagittal ankle moment bottom. All parameters are measured during gait with E-Mag in the locked dark grey and the unlocked mode light grey. Compensatory movements were reduced with the SCO in the unlocked mode. More specifically, hip hiking was reduced in 6 out of 8 subjects based on the angle of pelvis tilt obliquity in the coronal plane.

Additionally, vaulting was reduced in 2 out of 3 subjects based on the sagittal angle and moment of the ankle. The mean ratings of the Device subscale score were 4. The mean ratings for each question are shown in Table 3. Table 3. As far as the importance of the satisfaction items for the patients is concerned, safety was selected most often 7 times with an average rating of 3.

Timed walk tests are validated measures of physical performance and overall mobility in the elderly and patients with various medical conditions [], including incomplete spinal cord injury [], post-polio syndrome [] and lower limb amputations []. In subjects with lower limb amputations, the distance walked is well correlated with daily activity and indicative for substantial functional limitations in daily life [33,34].

Timed walk tests have not yet been validated specifically for users of KAFOs, but for patients with neurologic conditions that may require fitting of a KAFO such as incomplete SCI, stroke, traumatic brain injury, or multiple sclerosis []. The results of our study show that subjects walked significantly slower in the locked mode compared to the unlocked mode of the SCO. The average difference in walking speed between the orthotic modes was bigger in the 6MWT with 0.

In the literature, seven studies reported comparable parameters determined in 3D gait measurements. In five of these studies, subjects demonstrated a significantly faster or at least a tendency toward faster walking speed between 0. With the E-MAG Active in the locked condition, subjects were significantly restricted in their functional walking capacity as demonstrated by a mean This difference and thus the effect of the SCO mode on the functional walking capacity is close to the reported minimal clinically important differences MCID for incomplete SCI 36 m [22] and stroke rehabilitation Using the SCO mode, subjects reached almost exactly the normative value of Thus, it can be concluded that walking with an orthosis with a locked knee joint results in a significantly reduced functional walking capacity as compared to walking with an SCO with an unlocked knee.

Our results demonstrate that the difference in walking speed in the 6MWT was bigger than in the short distance gait analysis. This suggests that lab-based assessments alone may not be sufficient to evaluate interventions as they may underestimate the magnitude of clinical benefits compared to clinical outcome measures. The difference in walking distance or walking speed, respectively, between the orthotic modes is probably caused by the fact that walking with a locked orthotic knee requires a multitude of compensatory movements such as hip hiking and vaulting to generate enough toe clearance to prevent stumbles and falls [,43,44].

We were able to confirm these compensatory movements in our sample when walking with the orthosis in the locked mode.

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As the orthotic knee joint allows for bending and thus sufficient toe clearance during swing, compensatory movements may be substantially reduced: Lifting of the pelvis on the orthotic side may be diminished and untimely plantar flexion of the sound foot may be reduced, resulting in a decreased sagittal ankle moment Figure 1. These results are in accordance with previous studies. Zissimopoulos, et al. Schmalz, et al. Irby, et al.


In this group, the mean satisfaction with the device was only 3. Thus, satisfaction with the SCO used at study entry may be slightly above average for orthotic devices in general. A general characteristic of all SCOs is that the proper function of the orthosis, especially the locking for stance and unlocking for swing, must be controlled by the patient. This requires certain residual functions and a permanent concentration on the gait.

It is quite likely that users have experienced in their daily lives, for example in situations with increasing physical fatigue, that the locking of the orthotic knee joint may be vulnerable [51]. Research and development have meanwhile addressed some of the technical challenges of the control mechanisms of SCOs. Clinical decision making may meanwhile also consider a microprocessor controlled hydraulic orthotic knee joint that enables knee flexion during weight bearing as required for reciprocal slope and stair descent and provides increased perceived safety in many activities of daily living [51,52].

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