The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Luna EMG
lower limb rotor
Sponsored by

About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke,, rehabilitation,, EMG-triggered rehabilitation,, robotic-assisted movement,, gait
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)
Sites / Locations
- Rehstab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study Group
Control Group
Arm Description
A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device.
A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor
Outcomes
Primary Outcome Measures
Change in Timed up and go test results
the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair
Change in Ashworth Scale results
Measurement of resistance during passive knee flexion and extension
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.
Change in Rivermeade Motor Assessment (RMA)
The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers.
Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.
change in REPTY questionnair results
a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)
Change in Tight Circumference
thigh circumferences (5 and 15 centimeters above the patella),
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04497545
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2019 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EGZOTech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
stroke,, rehabilitation,, EMG-triggered rehabilitation,, robotic-assisted movement,, gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device.
Arm Title
Control Group
Arm Type
Other
Arm Description
A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor
Intervention Type
Device
Intervention Name(s)
Luna EMG
Intervention Description
The duration of the overall therapeutic intervention in both groups will be the same.
Intervention Type
Device
Intervention Name(s)
lower limb rotor
Intervention Description
The duration of the overall therapeutic intervention in both groups will be the same.
Primary Outcome Measure Information:
Title
Change in Timed up and go test results
Description
the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair
Time Frame
baseline, after 4 weeks, after 6 weeks
Title
Change in Ashworth Scale results
Description
Measurement of resistance during passive knee flexion and extension
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.
Time Frame
baseline, after 4 weeks, after 6 weeks
Title
Change in Rivermeade Motor Assessment (RMA)
Description
The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers.
Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.
Time Frame
baseline, after 4 weeks, after 6 weeks
Title
change in REPTY questionnair results
Description
a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)
Time Frame
baseline, after 4 weeks, after 6 weeks
Title
Change in Tight Circumference
Description
thigh circumferences (5 and 15 centimeters above the patella),
Time Frame
baseline, after 4 weeks, after 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Rehstab
City
Limanowa
State/Province
Malopolskie Voivodship
ZIP/Postal Code
34-600
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients
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