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Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03888118
Enrollment
60
Registered
2019-03-25
Start date
2019-04-01
Completion date
2020-03-31
Last updated
2019-03-25

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

Conditions

Stroke

Keywords

Luna EMG, drop foot, chronic stroke

Brief summary

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.

Interventions

DEVICELuna EMG

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

Sponsors

Rehamed Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lovett scale1 minuteThe muscle strength in Lovett scale is graded on a scale of 0-5: Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance. Grade 3:Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. Grade 2: Muscle can move only if the resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle. Grade 0: No movement is observed. Higher values represent a better outcome. We'd like to asses foot dorsiflexor muscle strength.
EMG using the Luna EMG3 minutesEMG will be performed using the Luna EMG device also allowing the treatment and diagnosis. With Luna EMG we can supply objective, data driven diagnosis. Innervation diagnosis and motor unit recruitment through surface electromyography. We'd like to assess bioelectrical activity at the tibialis anterior muscle during relaxing for two minutes (mean, minimum and maximum electrical activity in muscle - in microvolts).
Ashworth scale1 minuteMeasurement of resistance during passive plantarflexion and dorsiflexion. Scorse range from 0 to 4, with 5 choices: Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal. resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved. Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.
Tinetti test - gait and balance10 minutesThe Tinetti Balance and Gait test is a standardized evaluation of mobility and stability. Balance and gait are assessed and scored individually in a 16-item test. A three-point ordinal scale, ranging from 0-2. 0 indicates the highest level of impairment and 2 the individuals independence. Gait is scored 0-12 and balance is scored 0-16. Total Test Score is maximum 28. Interpretation: 25-28 low fall risk 19-24 medium fall risk \< 19 high fall risk Higher score represent a better outcome.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026