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

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.

Conditions

• Ankle Fractures

Interventions

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.

Sponsors & Collaborators

• Istituto Italiano di Tecnologia

  collaborator OTHER

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

  lead OTHER

Principal Investigators

• Paolo Catitti, MD · INAIL - Centro di Riabilitazione Motoria di Volterra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• Italy

Study Locations