- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162263
Improving Functional Outcomes and Neuroplasticity by Using Ekso
Does Ekso Improve Motor Function and Neuroplasticity in Pazients Affected by Chronic Stroke? A Rondomized Pilot Study
The use of neurorobotic devices into gait rehabilitative programs, including Ekso, is reported to increase the engagement and motivation of the patients while actively performing a task, and to shape the sensory-motor plasticity (SMP) and its balance between the primary motor areas (M1), and the fronto-parietal network (FPN) connectivity, thus contributing to successful gait rehabilitation. Aim of our study was to assess whether Ekso would foster the recovery of deteriorated FPN connectivity and SMP patterns involved in limb coordination during walking in a sample of patients with hemiparesis due to stroke.
Twenty outpatients were consecutively included in this study according to the following inclusion criteria: (i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) >24; (v) a Modified Ashworth Scale (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant neurodegenerative diseases or brain surgery.
Patients were randomly assigned to the experimental (Ekso gait training -EGT) of control group (conventional overground gait training -OGT- at a velocity matched to the Ekso gait training).
Study Overview
Detailed Description
Ekso (Ekso Bionics; Richmond -CA- USA) is a wearable robot consisting of an exoskeleton framework for the lower limbs with (1) electric motors to power movement for the hip and knee joints, (2) passive spring-loaded ankle joints, (3) foot plates on which the user stands, and (4) a backpack that houses a computer, battery supply, and wired controller. A rigid backpack is an integral structural component of the exoskeleton, which provides support from the posterior pelvis to the upper back, besides carrying the computer and batteries. The exoskeleton attaches to the user's body with straps over the dorsum of the foot, anterior shin and thigh, abdomen, and anterior shoulders. The limb and pelvic segments are adjustable to the user's leg and thigh length, and the segment across the pelvis is adjustable for hip width and hip abduction angle. We preliminarily measured M1-leg excitability and SMI, which were probed using TMS pulses with a monophasic pulse configuration and peripheral nerve electric stimuli. Single magnetic pulses were given to the affected and unaffected leg-M1 using a standard figure-of-eight coil (diameter of each wing, 90 mm) connected with a high-power Magstim200 stimulator (Magstim Co, Ltd; UK).
Effective connectivity (that measures the causal influence that one brain area exerts over another under the assumption of a given mechanistic model) was assessed using a structural equation modelling (SEM). An 8-channel wireless surface EMG (sEMG) device (BTS; Milan, Italy) was used to record EMG activity from eight muscles (both tibialis anterior -TA-, soleus -S-, rectus femoris -RF-, and biceps femoris -BF). The device was also equipped with an accelerometer, put at lumbar level, to establish gait phases. Gait analysis was conducted on a 10-meter walkway.
We measured the following gait measures for both the affected and unaffected lower limb [20]: (i) step cadence (number of steps per minute; normal values 1.9±0.1 Hz);. (ii) gait cycle duration (time from one right heel strike -initial contact- to the next one -end of terminal swing; normal values 1.1±0.1 sec); (iii) stance/swing ratio (ratio between stance from heel strike to toe-off, and swing phase duration from toe-off to heel strike; normal values 1.5±0.1); .and (iv) an overall gait performance score (gait index, reflecting an approximate 60:40% distribution of stance:swing phases; normal values >90).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Messina, Italy, 98123
- IRCCS Centro Neurolesi Bonino-Pulejo"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) >24; (v) a Modified Ashworth Scale (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant neurodegenerative diseases or brain surgery.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ekso training
All patients underwent twenty-four Ekso sessions, scheduled 3 times a week.
Each session lasted about 1h, and included transferring into the device arranged on an office chair; donning, standing, walking, sitting, doffing; and transferring out of the exoskeleton.The user can stand up, sit down, and walk with help of a front-wheeled walker and with the exoskeleton attached to a ceiling rail tether.
A physical therapist initially provides assistance to maintain the user's center of mass over the base of support to prevent falling.
|
Patients affected by chronic stroke underwent gait training by using the Ekso device; they performed a total of 20 sessions (5 day/week for 4 weeks) of at leat 40min duration.
|
Active Comparator: Overground training
Conventional gait training overground; before the training 10 min lower limb muscular exercises and stretching were performed by the physiotherapist.
The overground training had the same duration of the Ekso training.
|
Patients affected by chronic stroke underwent gait training by using the Ekso device; they performed a total of 20 sessions (5 day/week for 4 weeks) of at leat 40min duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motricity Index
Time Frame: Six months
|
a measure to evaluate lower limb motor function
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frontoparietotemporal connettivity
Time Frame: Six months
|
an EEG evaluation of the patient's plasticity
|
Six months
|
Collaborators and Investigators
Investigators
- Study Chair: Placido Bramanti, MD, IRCCS Neurolesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on EKso training
-
Vrije Universiteit BrusselTerminated
-
Shirley Ryan AbilityLabU.S. Department of EducationActive, not recruiting
-
The University of Hong KongHospital Authority, Hong KongRecruiting
-
Sunnyview Rehabilitation HospitalRecruitingStroke | Stroke, Acute | Cerebrovascular Accident | Cerebrovascular Accident, AcuteUnited States
-
Azienda Usl di BolognaIRCCS Institute of Neurological Sciences of Bologna (Italy); Department of... and other collaboratorsRecruiting
-
Kessler FoundationNew Jersey Commission on Spinal Cord ResearchUnknownSpinal Cord InjuryUnited States
-
Shirley Ryan AbilityLabU.S. Department of EducationActive, not recruitingSevere Stroke or Similar Neurological Muscle WeaknessUnited States
-
Ekso BionicsTerminatedSpinal Cord InjuriesUnited States
-
Shirley Ryan AbilityLabUnited States Department of DefenseActive, not recruitingSpinal Cord Injuries or Similar Neurological WeaknessUnited States
-
Baylor Research InstituteUnited States Department of Defense; Texas Woman's UniversityRecruitingSpinal Cord InjuriesUnited States