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

NCT03805009 | Completed DMC

• 1 other identifier: RP 15/13
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Six-Minute Walking Test (6MWT)

  The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.

  Session 1 (baseline), and Session 20 (week 7)

Secondary Outcomes (10)

• Change in Fugl-Meyer Assessment (FMA) scale

  Session 1 (baseline), and Session 20 (week 7)

• Change in Motricity Index (MI)

  Session 1 (baseline), and Session 20 (week 7)

• Change in Modified Ashworth Scale (MAS)

  Session 1 (baseline), and Session 20 (week 7)

• Change in Tinetti Scale Balance (TIN-B)

  Session 1 (baseline), and Session 20 (week 7)

• Change in Tinetti Walking (TIN-W)

  Session 1 (baseline), and Session 20 (week 7)

Other Outcomes (2)

• Gait Analysis

  Session 1 (baseline), and Session 20 (week 7)

• Postural Analysis

  Session 1 (baseline), and Session 20 (week 7)

Study Arms (2)

Robotic Group (RG)

EXPERIMENTAL

Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.

Device: Robot-Assisted Gait Training (RAGT)

Conventional Group (CG)

NO INTERVENTION

Conventional Group (CG) will perform conventional gait rehabilitation program. The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.

Interventions

Robot-Assisted Gait Training (RAGT) DEVICE

The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).

Robotic Group (RG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first cerebral stroke
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (2)

IRCCS San Raffaele Pisana

Rome, RM, 00163, Italy

Location

Fondazione Don Carlo Gnocchi Onlus

Rome, RM, 00166, Italy

Location

Related Publications (23)

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MeSH Terms

Conditions

Stroke; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Cardiovascular Diseases; Gait Disorders, Neurologic; Paresis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Franceschini, MD

  IRCCS San Raffaele Pisana

  STUDY CHAIR

• Sanaz Pournajaf, Dr

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

• Michela Goffredo, Ing

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the clinical assessments are routinely administered by both participating centers, and the outcome assessors are blinded to the study protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded, non randomized, pilot study

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: March 19, 2013
• Primary Completion: December 31, 2017
• Study Completion: September 30, 2018
• Last Updated: April 10, 2024

Record last verified: 2023-06

Locations

IT (2)