I60 I61 I62 I63 I64
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Stroke > 6 months ago Patients > 18 years old • Ability to consent to participate in the study and follow instructions • Ability to communicate that the training session should be ended • Ability to walk at least 10 meters with or without assistance • Patient is able to tolerate electrical stimulation • Ability to completely lift the sole of the foot off the ground (at least 1 cm) • Visible response to electrical stimulation
Exclusion criteria
Exclusion criteria: • More than one stroke in history, unless the patient had no neurological deficits from previous strokes. • Patients with poor compliance Epilepsy • Patients with pacemakers • Patients with heart or lung diseases • Skin lesions/local infections in the area of the sole of the foot where the electrodes are placed • Other neurological disorders • Pregnancy • The application of electrical stimulation is only carried out with the explicit consent of the specialist doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the study, evaluations were conducted at five different time points: initially as a baseline (T0), five weeks later as a second baseline (T1), after completing five weeks of therapy (T2), following a 12-week follow-up period (T3), and one year after the intervention (T4). a. 2-minute walk test with and without Incedo® (measured in meters) b. 10-meter walk test with and without Incedo® (measured in seconds). | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Video recordings of the patient's gait before and after the training period (T1 and T3). b. Assessment of the sensitivity of the affected foot (at all measurement points from T0 to T4). c. After the training period, a written survey on the acceptance of the therapy device was conducted using the User Satisfaction Evaluation Questionnaire (USEQ) (T3). | — |
Countries
Germany
Contacts
Kliniken Schmieder Allensbach