NCT02923479

Robot-assisted Rehabilitation of Ankle Fractures: Efficacy and Comparison With Traditional Methods

Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the effectiveness, safety and tolerability of robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from work related ankle fractures, compared with conventional rehabilitation programs.

Detailed description

INTRODUCTION: Robotic devices for lower-limb rehabilitation have been mainly tested in neurologically injured patients. Up to now, clinical studies using robotic training in orthopedic conditions are few. A pilot study was carried out at INAIL Physical Rehabilitation Center of Volterra using ARBOT, a prototypal robotic system for ankle rehabilitation. This device has been developed by IIT - Italian Institute of Technology and it consists of a two-degree-of-freedom electromechanical platform which is able to perform most of the exercises foreseen by the standard rehabilitation programs. By virtue of its innovative motion system and control architecture, ARBOT integrates multiple rehabilitation equipment functions, performing also special exercise programs such as elastic and fluid-dynamic resistance. ARBOT allows training according to programmed sequences, in order to promote range of movement, muscular function and proprioceptive recovery. Exercises can be performed with or without bearing weight. Moreover, ARBOT is a powerful evaluation instrument for physiotherapists in order to verify and record the results of rehabilitative intervention. The primary aim of this trial was to determine the effectiveness, safety and tolerability of robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from work related ankle fractures, compared with conventional rehabilitation programs. Secondary objectives was to investigate correlations among physical and disability parameters, to collect data in order to define further study protocols and improve ARBOT's performance and ergonomics, and ultimately to evaluate patient satisfaction with respect to robot assisted rehabilitation programs. METHODS: Thirty-two patients with work related injuries resulting in ankle and/or hindfoot fractures and subsequent to the immobilization phase was enrolled in an open randomized controlled trial over a 30 month period. Each participant was randomly allocated to experimental or control group and received a 4-week rehabilitation program (20 sessions, for 5 days/week from admission to discharge in the Rehabilitation Centre) and weekly robotic and clinical assessments. Subjects in the experimental group were treated using ARBOT with passive, active and active assisted range-of-motion exercises, resistive exercises in isometric, isotonic, isokinetic, elastic and fluid-dynamic conditions, and proprioceptive training. Control subjects were assisted by a physiotherapist during range of motion recovery exercises and performed resistive and proprioceptive training using Biodex System 3 dynamometer and ProKin PK254 mobile electronic platform. The assessment sessions included measurements of dorsiflexion ROM, isometric and isokinetic plantar-flexion torque and proprioceptive performance with ARBOT and 2 minutes walking and timed stair climbing test, LEFS-Lower Extremity Functional Scale and AOFAS-Ankle-Hindfoot Scale. Site monitoring of the study has been conducted according to the standard ISO 14155.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
DEVICE	Specific ankle rehabilitation by ARBOT device	ARBOT is a programmable robotic device consisting in a two-degree-of-freedom electromechanical platform developed by Italian Institute of Technology - Advanced Robotics and Rehab Technologies. It is composed of a fixed base, a central strut, a moving platform supporting patient's foot and three actuated limbs with a universal-prismatic-spherical kinematic chain. A six-axis force/torque sensor mounted between the moving platform and the footplate senses the human-robot interaction force and torque. The device is interfaced to a standard all-in-one touch screen Personal Computer with graphic applications to give patients visual feedback in real time.
OTHER	General Rehabilitation	All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.
OTHER	Specific ankle rehabilitation performed by physiotherapist	Subjects in the control group underwent manually assisted range of motion exercises.
DEVICE	Specific ankle rehabilitation by Biodex System 3 dynamometer	Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer
DEVICE	Specific ankle rehabilitation by ProKin PK254 platform	Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2016-10-04
• Last updated: 2016-10-04

Locations

1 site across 1 country: Italy