Efficacy of End-Effector Robot-Assisted Gait Training Combined With Robotic Balance Training in Subacute Stroke Patients

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Stroke

Treatments: Device: GEO and HUNOVA; Device: GEO

Study type: Interventional

Funder types: Other

Identifiers

NCT04162197

FDG_GEOHUN

Details and patient eligibility

About

Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has aroused great interest. Some studies have been conducted to evaluate the effects of robot-assisted training compared to conventional gait rehabilitation in patients with subacute stroke but no studies seem to investigate the effects of a combined robotic treatment (gait plus balance).

The aim of this study is to evaluate the efficacy of a combined gait and balance robotic rehabilitation compared robotic gait training alone.

Full description

Stroke is not only the third cause of death after cardiovascular disease and cancer, but also the first cause of disability in the world with a significant impact on individuals, their families and finances. Post-stroke disability involves mobility and balance, muscle strength, control of movement, and gait pattern functions. Although the majority of stroke patients learns to walk independently by 6 months after stroke, gait and balance problems persist through the chronic stage and may have a significant impact on patients' quality of life. Accordingly, the restoration and improvement of walking functions is a primary concern to obtain independence in daily life. For this reason, gait recovery is a realist goal in the rehabilitation of almost all patients with stroke. The recovery of a more fluid, safe and correct execution of motor tasks such as gait and stair climbing are a prerequisite for the patients to become autonomous in the activities of daily living.

Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has aroused great interest. Some studies have been conducted to evaluate the effects of robot-assisted training compared to conventional gait rehabilitation in patients with subacute stroke. The main results were obtained using robotic exoskeletons or a treadmill training with partial body weight support and only a few studies used an end-effector device. Preliminary studies have shown that end-effector Robot-Assisted Gait Training (RAGT) has produced promising effects on motor and functional outcomes in chronic and subacute strokes patients comparing with conventional treatment. Moreover, safe gait needs a continuous dynamic balance than it is possible that in gait robotic rehabilitation could be included a rehabilitation treatment of static and dynamic balance with a robotic proprioceptive platform. The hypothesis of the study is that a combined robotic treatment (gait plus balance) could produce more effects than just one robotic gait training.

Therefore, the aim of this study is to evaluate the efficacy of gait and balance robotic rehabilitation in subacute stroke patients in terms of clinical outcomes, balance measures and gait kinematics, comparing them with robotic gait training alone.

The patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis and Balance evaluation) at baseline (T0), after 12 sessions (T1) and at the end of the training program (24 sessions: T2). The patients will be randomized into 2 groups and will conduct two different types of rehabilitation training: one group will perform, gait training using an end-effector robotic device for RAGT (Gait Group, GG); and the other group will receive a combined robotic treatment program with the same end-effector robotic system and a robotic proprioceptive platform (Balance Group, GHG). The rehabilitation program of both groups will be combined with conventional physiotherapy.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• first cerebral stroke
• 1 month up to 6 months post the acute event (subacute patients)
• age between 18-85 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental 1: Gait Group (GG)

Experimental group

Description:

Gait Group (GG) will perform, in addition to conventional therapy, gait training using only an end effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 12 sessions/month. 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: GEO

Experimental 2: Balance Group (GHG)

Experimental group

Description:

Balance Group (GHG) will receive, in addition to conventional therapy, a combined robotic treatment program with the same end-effector robotic system and a robotic proprioceptive platform, 3 times/week for 12 sessions/month. The time of the single session (45 minutes) is dived in gait training and balance training. The balance training will consist in static and dynamic exercises during sitting and standing position, dual-task exercises and exercises aimed to improve trunk control.

Treatment:

Device: GEO and HUNOVA