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Improving Functional Outcomes and Neuroplasticity by Using Ekso

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EKso training
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Ekso, neuroplasticity, functional recovery

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • IRCCS Centro Neurolesi Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ekso training

Overground training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Motricity Index
a measure to evaluate lower limb motor function

Secondary Outcome Measures

Frontoparietotemporal connettivity
an EEG evaluation of the patient's plasticity

Full Information

First Posted
May 19, 2017
Last Updated
October 17, 2018
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT03162263
Brief Title
Improving Functional Outcomes and Neuroplasticity by Using Ekso
Official Title
Does Ekso Improve Motor Function and Neuroplasticity in Pazients Affected by Chronic Stroke? A Rondomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Ekso, neuroplasticity, functional recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ekso training
Arm Type
Experimental
Arm Description
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.
Arm Title
Overground training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EKso training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motricity Index
Description
a measure to evaluate lower limb motor function
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Frontoparietotemporal connettivity
Description
an EEG evaluation of the patient's plasticity
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Placido Bramanti, MD
Organizational Affiliation
IRCCS Neurolesi
Official's Role
Study Chair
Facility Information:
Facility Name
IRCCS Centro Neurolesi Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29695280
Citation
Calabro RS, Naro A, Russo M, Bramanti P, Carioti L, Balletta T, Buda A, Manuli A, Filoni S, Bramanti A. Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. J Neuroeng Rehabil. 2018 Apr 25;15(1):35. doi: 10.1186/s12984-018-0377-8.
Results Reference
derived

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Improving Functional Outcomes and Neuroplasticity by Using Ekso

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