Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Stroke Clinical Trial

Official title:

Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03888118
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2019
• Source: Rehamed Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Luna EMG
The duration of the overall therapeutic intervention in both groups will be the same.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rehamed Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG using the Luna EMG	EMG 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).	3 minutes
Primary	EMG using the Luna EMG	EMG 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 activation patterns during three times dorsiflexion (mean, minimum and maximum electrical activity in muscle - in microvolts).	1 minute
Primary	Lovett scale	The 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.	1 minute
Primary	Ashworth scale	Measurement 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.	1 minute
Primary	Tinetti test - gait and balance	The 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.	10 minutes