German Clinical Trials Register

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Brief summary in lay language

Improving walking ability is an important goal in the neurological rehabilitation of stroke patients. Increasingly, gait training is carried out in combination with electrical stimulation of the lower extremity. The aim of this study is to test the effect of treadmill-based gait training in combination with electrostimulation using the Incedo system on subacute patients who are unable to walk independently after a stroke. The study is intended to improve therapy options for patients with stroke. The electrostimulation is carried out with the Incedo system. Stimulation of the foot sole activates the so-called flexor reflex, which triggers a reflexive flexion in the leg. The test persons are divided into either the intervention group or the control group. For the classification, the general walking ability on the floor and the walking performance on the treadmill with and without electrical stimulation on the foot sole are first recorded. The study consists of a pre- and post-test and a 6-week training period. In the pre- and post-tests, somatosensory testing, muscle function testing, spasticity testing, general walking ability testing, the 2-minute walking test on the treadmill and measurement of sensory evoked potentials (SEP's) from the tibial nerve will be performed. The testing of the muscle strength of the affected leg as well as the testing of the general walking ability on the floor and the walking performance on the treadmill are filmed. At all three test points, the BORG scale is used to determine how demanding walking on the treadmill is for the patient. In addition, a questionnaire is used to test how physically demanding it is for the physiotherapist to support the patient while walking on the treadmill. During the 6-week training period, the patients in the intervention group receive 30 minutes of gait training twice a week on the treadmill with combined electrostimulation (Incedo-system) of the affected leg. The patients in the control group receive the same amount of training without electrostimulation of the affected leg. Each patient will complete a total of 12 training sessions. Six weeks after the training, if possible, the same tests as before the training and immediately afterwards are carried out. The gait training takes place within the regular physiotherapy sessions. It is not an add-on intervention.

Brief summary in scientific language

Improving walking ability is an important goal in the neurological rehabilitation of stroke patients. Increasingly, gait training is carried out in combination with electrical stimulation of the lower extremity. The study examines whether treadmill-based gait training in combination with the Incedo-system can improve walking performance and gait parameters in subacute non-ambulatory patients with severe stroke-related hemiparesis? Subacute stroke patients who are unable to walk independently will be recruited and assigned to either the intervention or the control group according to the case-control principle. The results in the Functional Ambulations Categoris (0 - 1) and the results in the 2-minute walking test on the treadmill will be used as criteria for allocation to the groups. There is a baseline-test before the start of the training and a post-test directly after the six weeks of training. A follow-up test is conducted after a further six weeks. The following parameters are recorded at each test time: - Modified muscle function test - Somatosensory test - Measurement of spasticity (Tardieu-Scale) - Assessment of walking ability (Functional Ambulation Categories) - Two-minute walking test on the treadmill (with and without Incedo- system). With recording of: a) Amount of weight relief b) Distance covered c) Number of steps d) Degree of exertion for patients (BORG scale) e) Degree of effort for therapists (questionnaire) - Video recordings of the muscle strength of the affected leg as well as the patient's gait pattern on the floor and the treadmill. - Sensory evoked potentials (SEP) of N. tibialis During the 6-week training period, the patients in the intervention group receive 30 minutes of gait training twice a week on the treadmill with combined electrostimulation (Incedo-system) of the affected leg. The patients in the control group receive the same amount of training, but without electrostimulation of the affected leg. In total, each patient should complete 12 training units. The gait training takes place within the regular physiotherapy sessions. It is not an add-on intervention.