Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
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|ClinicalTrials.gov Identifier: NCT03888118|
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Luna EMG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: 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.
Device: Luna EMG
The duration of the overall therapeutic intervention in both groups will be the same.
No Intervention: Control group
A four-week rehabilitation program (Monday to Friday) involving two hours of individual ankle therapy.
- EMG using the Luna EMG [ Time Frame: 3 minutes ]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).
- EMG using the Luna EMG [ Time Frame: 1 minute ]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).
- Lovett scale [ Time Frame: 1 minute ]
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.
- Ashworth scale [ Time Frame: 1 minute ]
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.
- Tinetti test - gait and balance [ Time Frame: 10 minutes ]
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.
25-28 low fall risk 19-24 medium fall risk < 19 high fall risk Higher score represent a better outcome.