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

NCT ID: NCT02923479

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: ARBOT Group

The patients in the "ARBOT Group" underwent to following interventions:

1. General Rehabilitation

2. Specific ankle rehabilitation by ARBOT device

Group Type: EXPERIMENTAL

Specific ankle rehabilitation by ARBOT device

Intervention Type: 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.

General Rehabilitation

Intervention Type: OTHER

All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.

Control Group

The patients in the Control Group underwent to following interventions:

1. General Rehabilitation

2. Specific ankle rehabilitation performed by physiotherapist

3. Specific ankle rehabilitation by Biodex System 3 dynamometer

4. Specific ankle rehabilitation by ProKin PK254 platform.

Group Type: OTHER

General Rehabilitation

Intervention Type: OTHER

All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.

Specific ankle rehabilitation performed by physiotherapist

Intervention Type: OTHER

Subjects in the control group underwent manually assisted range of motion exercises.

Specific ankle rehabilitation by Biodex System 3 dynamometer

Intervention Type: DEVICE

Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer

Specific ankle rehabilitation by ProKin PK254 platform

Intervention Type: DEVICE

Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Specific ankle rehabilitation performed by physiotherapist

Subjects in the control group underwent manually assisted range of motion exercises.

Intervention Type: OTHER

Specific ankle rehabilitation by Biodex System 3 dynamometer

Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Functional limitation following work-related ankle injuries, including:

• Malleolar and/or tibial shaft fractures, both surgically and conservatively treated;
• Distal tibia and fibula fractures, both surgically and conservatively treated;
• Hindfoot (Calcaneus and Talus) fractures, both surgically and conservatively treated.

2. Post-immobilization phase;

3. Time interval since fracture event of less than 12 months;

4. Signed informed consent acquisition.

Exclusion Criteria

1. Non-compliance with study requirements;

2. Pregnancy or breast feeding;

3. Current or prior history of malignancy;

4. Open skin at the level of the patient-device interface;

5. Sensory deficit at the level of the patient-device interface;

6. Ankle motor deficit secondary to peroneal or tibial neuropathy;

7. Acute inflammatory arthritis of the ankle;

8. Other pathological conditions inducing lower limb pain or disfunction.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Italiano di Tecnologia

OTHER

Sponsor Role: collaborator

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Catitti, MD

Role: PRINCIPAL_INVESTIGATOR

INAIL - Centro di Riabilitazione Motoria di Volterra

Locations

INAIL - Centro di Riabilitazione Motoria di Volterra

Volterra, Pisa, Italy

Countries

Italy

References

Saglia JA, Tsagarakis NG, Dai JS, Caldwell DG. Control Strategies for Patient-Assisted Training Using the Ankle Rehabilitation Robot (ARBOT). IEEE ASME TRANSACTIONS ON MECHATRONICS 2013; PP (99): 1-10.

Reference Type: BACKGROUND

Saglia JA, Tsagarakis NG, Dai JS, Caldwell DG. A high-performance redundantly actuated parallel mechanism for ankle rehabilitation. International Journal of Robotics Research 2009; 28 (9): 1216-1227.

Reference Type: BACKGROUND

Saglia JA, Tsagarakis NG, Dai JS, Caldwell DG. Inverse-Kinematics-Based Control of a Redundantly Actuated Platform for Rehabilitation. Journal of Systems and Control Engineering, IMechE Proceedings 2009; 223 (1): 53-70.

Reference Type: BACKGROUND

Other Identifiers

CRMINAIL01

Identifier Type: -

Identifier Source: org_study_id