Clinical trial NCT04497545: The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients
Official title: The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: stroke,
rehabilitation,
EMG-triggered rehabilitation,
robotic-assisted movement,
gait
Lead sponsor: EGZOTech
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 71
Sex: ALL
Minimum age (years): 29
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.


Eligibility criteria: Inclusion Criteria:

* ischemic stroke,
* not later than 6 months ago,
* muscle strength of extensors and knee flexors on the Lovetta scale below 3,
* functional disorders of the lower limb,
* patient's condition allowing full understanding of commands
* continued/uninterrupted rehabilitation process for 28 days

Exclusion Criteria:

* cognitive impairment-lack of or poor cooperation between the patient and the therapist,
* stroke (more than 6 months after the incident),
* unstable clinical condition,
* muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
* rigid fixed contractures within the lower limb,
* significant spasticity (Ashworth scale of 3 and above)

Primary outcomes:
measure: Change in Timed up and go test results
timeFrame: baseline, after 4 weeks, after 6 weeks
measure: Change in Ashworth Scale results
timeFrame: baseline, after 4 weeks, after 6 weeks
measure: Change in Rivermeade Motor Assessment (RMA)
timeFrame: baseline, after 4 weeks, after 6 weeks
measure: change in REPTY questionnair results
timeFrame: baseline, after 4 weeks, after 6 weeks
measure: Change in Tight Circumference
timeFrame: baseline, after 4 weeks, after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Limanowa
country: Poland
facility: Rehstab
state: Malopolskie Voivodship
Study officials:
References: