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?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031889

Enrollment

Registered

2023-06-14

Start date

2023-08-30

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I60 I61 I62 I63 I64

Interventions

Group 1: Intervention group: 4 times a week stimulation with the Incedo-system on the foot sole of the affected leg to trigger the flexor reflex, in addition to regular physiotherapy. 10 rounds of 10

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. There is a pre-test before the start of the training, an intermediate-test after 10 training sessions and a post-test after 20 training sessions. 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) - Video recording, showing the active mobility of the affected leg and the patient's gait pattern - Sensory evoked potentials (SEP) of N. tibialis	—

Measure

Time frame

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. There is a pre-test before the start of the training, an intermediate-test after 10 training sessions and a post-test after 20 training sessions. 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) - Video recording, showing the active mobility of the affected leg and the patient's gait pattern - Sensory evoked potentials (SEP) of N. tibialis

—

Countries

Germany

Contacts

Public ContactJana Stürner

Lurija Institut

j.stuerner@kliniken-schmieder.de07533 808 1404

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026