Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study Group

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

Group Type EXPERIMENTAL

Luna EMG

Intervention Type DEVICE

The duration of the overall therapeutic intervention in both groups will be the same.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Luna EMG

The duration of the overall therapeutic intervention in both groups will be the same.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No