Does electrostimulation with the Incedo in the supine position improve muscle activity in the affected lower limb as well as walking performance in non-ambulatory patients after stroke?

Not Applicable

Recruiting

Conditions: I60
I61
I62
I63
I64
Subarachnoid haemorrhage
Intracerebral haemorrhage
Other nontraumatic intracranial haemorrhage
Cerebral infarction
Stroke, not specified as haemorrhage or infarction

Registration Number: DRKS00031889

Lead Sponsor: urija Institut, Kliniken Schmieder Allensbach

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Stroke < 3 months
- Severe paresis of the lower limb
- Patients who are unable to walk or who can only walk with the permanent
support of at least two assistants (Functional Ambulation Categories: 0)
- Patients with whom it is not yet possible to carry out treadmill-supported
gait training with weight support (e.g. due to the severity of the illness,
vegetative instability, etc.).
- Patients tolerated the electrostimulation well
- A visible flexor reflex can be triggered in the affected leg in supine position
- Ability to understand the instructions and to give informed consent for the
participation in the study
- Ability to communicate
- Electrostimulation is only used with the consent of the doctor treating the
patient

Exclusion Criteria

- More than one stroke in the history, unless the patient has no neurological
deficits from the previous strokes.
- Other neurological diseases
- Lack of compliance
- Epilepsy
- Patients with heart pacemakers
- Patients with severe heart or lung diseases
- Patients with cancer
- Skin lesions in the area where the electrode is positioned
- Pregnancy
- Patients who adjust to the electrical stimulus in a short time or patients in
whom a higher stimulation intensity triggers spasticity or clonus in the
affected leg

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of the study is to determine whether electrical stimulation of the foot sole in a supine position leads to an improvement in the muscle strength of the affected leg and to an improvement in the ability to walk in patients who were unable to walk. <br><br>There is a pre-test before the start of the training, an intermediate-test after 15 training sessions and a post-test after 30 training sessions. The following parameters are recorded at each test time: <br><br>- Modified muscle function test <br>- Somatosensory test<br>- Measurement of spasticity (Tardieu-Scale) <br>- Assessment of walking ability (Functional Ambulation Categories) <br>- Video recording, showing the active mobility of the affected leg and the patient's gait pattern<br>- Sensory evoked potentials (SEP) of N. tibialis

Secondary Outcome Measures