Improving Functional Outcomes and Neuroplasticity by Using Ekso

NCT03162263 | Completed DMC

• 1 other identifier: 43/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Ekso; neuroplasticity; functional recovery

Outcome Measures

Primary Outcomes (1)

• Motricity Index

  a measure to evaluate lower limb motor function

  Six months

Secondary Outcomes (1)

• Frontoparietotemporal connettivity

  Six months

Study Arms (2)

Ekso training

EXPERIMENTAL

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.

Device: EKso training

Overground training

ACTIVE COMPARATOR

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.

Device: EKso training

Interventions

EKso training 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.

Ekso training; Overground training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino-Pulejo"

Messina, 98123, Italy

Location

Related Publications (1)

• 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.

  PMID: 29695280 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Placido Bramanti, MD

  IRCCS Neurolesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: May 1, 2017
• Primary Completion: May 25, 2017
• Study Completion: July 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2017-08

Locations

IT (1)