Does gait training with the Incedo™ improve walking performance and gait parameters in subacute ambulatory patients with stroke-related hemiparesis?

Not Applicable

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: DRKS00031780

Lead Sponsor: urija Institut Kliniken Schmieder Allensbach

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

•Stroke < 6 months
•Patients > 18 years old
•Functional Ambulation Categories (FAC): [2,3 and 4]. A score of 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous or intermittent manual contact [2], or verbal supervision/guarding [3]. A score 4 indicates a patient who can ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, nonlevel surfaces).
•Patients had to be able to walk without orthoses for at least 10 meters.
•Electrostimulation is only used with the consent of the doctor treating the patient.
•Patients tolerated the electrostimulation well.
•A visible flexor reflex can be triggered in the affected leg while sitting and walking
•Ability to understand the instructions and to give informed consent for the participation in the study.

Exclusion Criteria

•Prior history of neurological illnesses or psychiatric conditions.
•Lack of compliance.
•Epilepsy.
•Patients with heart pacemakers, severe heart or lung diseases, cancer.
•Skin lesions in the area where the electrode is positioned.
•Pregnancy.
•Patients who adjust to the electrical stimulus within 30 minutes or patients in whom a higher stimulation intensity triggers spasticity in the affected leg.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
10-meter walk test; 2-minute walk test; Video analysis of the gait pattern.

Secondary Outcome Measures

Name	Time	Method
Modified muscle function test; Surface sensitivity on the sole of the foot; Measurement of sensitive evoked potentials (SEPs) of tibial nerves; Spasticity; Physical activity in everyday life; Performance on the treadmill.