Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients

Last updated: April 9, 2024
Sponsor: IRCCS San Raffaele Roma
Overall Status: Completed

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Atherosclerosis

Treatment

Robot-Assisted Gait Training (RAGT)

Clinical Study ID

NCT03805009
RP 15/13
  • Ages 18-80
  • All Genders

Study Summary

To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes.

The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • first cerebral stroke
  • 2 weeks up to 6 months post the acute event (subacute patients)
  • age between 18-80 years
  • ability to fit into the end-effector footplates
  • no significant limitation of joint range of motion
  • ability to tolerate upright standing for 60 seconds
  • ability to walk unassisted or with little assistance
  • ability to give written consent
  • compliance with the study procedures

Exclusion

Exclusion Criteria:

  • contractures of the hip, knee, or ankle joints that might limit the range of motionduring gait
  • medical issue that precludes full weight bearing and ambulation (e.g. orthopaedicinjuries, pain, severe osteoporosis, or severe spasticity)
  • cognitive and/or communicative disability (e.g. due to brain injury): inability tounderstand the instructions required for the study
  • cardiac pathologies, anxiety or psychosis that might interfere with the use of theequipment or testing Written informed consent was obtained from each subject.

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Robot-Assisted Gait Training (RAGT)
Phase:
Study Start date:
March 19, 2013
Estimated Completion Date:
September 30, 2018

Study Description

To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program, patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end of training program (T1). The patients will be divided into 2 groups and will conduct two different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of Rome and will perform, in addition to conventional therapy, gait training using an end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait rehabilitation program(Conventional Group, CG).

Connect with a study center

  • Fondazione Don Carlo Gnocchi Onlus

    Rome, RM 00166
    Italy

    Site Not Available

  • IRCCS San Raffaele Pisana

    Rome, RM 00163
    Italy

    Site Not Available

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