Clinical trial NCT03805009: Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients
Official title: Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Stroke
Acute Stroke
Mild Stroke
Central Nervous System Diseases
Cerebrovascular Disease
Brain Diseases
Cardiovascular Diseases
Gait, Hemiplegic
Keywords: Stroke
Robot
Hemiparesis
Gait Training
Rehabilitation
Functional Recovery
Robot-Assisted Gait Training
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2019-01-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, non randomized, pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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 Criteria:

* contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
* medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
* cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
* cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing

Written informed consent was obtained from each subject.

Primary outcomes:
measure: Change in Six-Minute Walking Test (6MWT)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA) scale
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Motricity Index (MI)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Tinetti Scale Balance (TIN-B)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Tinetti Walking (TIN-W)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Functional Ambulation Classification (FAC)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Trunk Control Test (TCT)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in 10 Meter Walk Test (10MWT)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Time Up And Go (TUG)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Change in Walking Handicap Scale (WHS)
timeFrame: Session 1 (baseline), and Session 20 (week 7)
Other outcomes:
measure: Gait Analysis
timeFrame: Session 1 (baseline), and Session 20 (week 7)
measure: Postural Analysis
timeFrame: Session 1 (baseline), and Session 20 (week 7)
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana
state: RM
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
state: RM
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Marco Franceschini, MD
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele Pisana
name: Sanaz Pournajaf, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Pisana
name: Michela Goffredo, Ing
role: PRINCIPAL_INVESTIGATOR
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