Improving Functional Outcomes and Neuroplasticity by Using Ekso

NCT ID: NCT03162263

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2017-07-01

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).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

EKso training

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

EKso training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Placido Bramanti, MD

Role: STUDY_CHAIR

IRCCS Neurolesi

Locations

IRCCS Centro Neurolesi Bonino-Pulejo"

Messina, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 29695280 (View on PubMed)

Other Identifiers

43/2016

Identifier Type: -

Identifier Source: org_study_id