Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Rehamed Center

Status: Unknown

Conditions: Stroke

Treatments: Device: Luna EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT03888118

001

Details and patient eligibility

About

A lot of studies prove that rehabilitation with the use of modern devices accelerates the recovery of function in patients after stroke. Repeated correct movement patterns affect the central nervous system and stimulating its plasticity. Despite the fact that so many studies confirm the validity of therapy using robots, it is still difficult to assess to what extent its use improves the effectiveness of traditional therapy. In these studies, we want to objectively assess the effectiveness of the Luna device using EMG biofeedback.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 6 months after stroke,
• tibialis anterior strength (Lovett scale) not less than 1 and not greater than 3,
• Ashworth scale in tibialis anterior 0,1, 2

Exclusion criteria

• patients less than 6 months after stroke,
• tibialis anterior strength (Lovett scale) 0, 4, 5,
• Ashworth scale in tibialis anterior higher than 2,
• damage to the central nervous system which is another incident,
• serious cognitive deficit,
• stiffness of the ankle.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Study Group

Experimental group

Description:

A four-week rehabilitation program (Monday to Friday) involving the hour of individual ankle therapy and one hour therapy on the Luna EMG device.

Treatment:

Device: Luna EMG

Control group

No Intervention group

Description:

A four-week rehabilitation program (Monday to Friday) involving two hours of individual ankle therapy.