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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923479
• Other study ID #: CRMINAIL01
• Status: Completed
• Phase: N/A
• First received: September 28, 2016
• Last updated: October 1, 2016
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

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.
• 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
• Specific ankle rehabilitation by ProKin PK254 platform
Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.

Locations

Country	Name	City	State
Italy	INAIL - Centro di Riabilitazione Motoria di Volterra	Volterra	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro	Istituto Italiano di Tecnologia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Dorsiflexion Range of Motion		At baseline and after 1, 2, 3 and 4 weeks intervention	No
Primary	Change of Isometric peak torque at 0° and 10° of plantar flexion		At baseline and after 2 and 4 weeks intervention	No
Primary	Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec		At baseline and after 2 and 4 weeks intervention	No
Primary	Change of 2 Minute Walk Test (2MWT)		At baseline and after 2 and 4 weeks intervention	No
Primary	Side Effects using ARBOT		Through study completion, up to 4 weeks	Yes
Secondary	Timed Stair Climbing Test (10 steps)		At baseline and after 2 and 4 weeks intervention	No
Secondary	Proprioceptive tests (time taking and accuracy)		At baseline and after after 2 and 4 weeks intervention	No
Secondary	Pain (VAS 0-10)		At baseline and after 1, 2, 3 and 4 weeks intervention	No
Secondary	LEFS - The Lower Extremity Functional Scale		At baseline and after after 4 weeks intervention	No
Secondary	AOFAS - Ankle-Hindfoot Scale		At baseline and after 4 weeks intervention	No
Secondary	Patient Satisfaction (VAS 0-10)		After 4 weeks intervention	No