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

IRCCS San Raffaele Roma

Status: Completed

Conditions: Severe Stroke; Cerebrovascular Disease; Central Nervous System Diseases; Cardiovascular Diseases; Mild Stroke; Gait, Hemiplegic; Acute Stroke; Brain Diseases

Treatments: Device: Robot-Assisted Gait Training (RAGT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03805009

RP 15/13

Details and patient eligibility

About

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.

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Robotic Group (RG)

Experimental group

Description:

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.

Treatment:

Device: Robot-Assisted Gait Training (RAGT)

Conventional Group (CG)

No Intervention group

Description:

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.