Clinical trial NCT02923479: Robot-assisted Rehabilitation of Ankle Fractures: Efficacy and Comparison With Traditional Methods
Official title: Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Keywords: Rehabilitation
Robotics
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
First posted: 2016-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of Dorsiflexion Range of Motion
timeFrame: At baseline and after 1, 2, 3 and 4 weeks intervention
measure: Change of Isometric peak torque at 0° and 10° of plantar flexion
timeFrame: At baseline and after 2 and 4 weeks intervention
measure: Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec
timeFrame: At baseline and after 2 and 4 weeks intervention
measure: Change of 2 Minute Walk Test (2MWT)
timeFrame: At baseline and after 2 and 4 weeks intervention
measure: Side Effects using ARBOT
timeFrame: Through study completion, up to 4 weeks
Secondary outcomes:
measure: Timed Stair Climbing Test (10 steps)
timeFrame: At baseline and after 2 and 4 weeks intervention
measure: Proprioceptive tests (time taking and accuracy)
timeFrame: At baseline and after after 2 and 4 weeks intervention
measure: Pain (VAS 0-10)
timeFrame: At baseline and after 1, 2, 3 and 4 weeks intervention
measure: LEFS - The Lower Extremity Functional Scale
timeFrame: At baseline and after after 4 weeks intervention
measure: AOFAS - Ankle-Hindfoot Scale
timeFrame: At baseline and after 4 weeks intervention
measure: Patient Satisfaction (VAS 0-10)
timeFrame: After 4 weeks intervention
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: INAIL - Centro di Riabilitazione Motoria di Volterra
state: Pisa
Study officials:
affiliation: INAIL - Centro di Riabilitazione Motoria di Volterra
name: Paolo Catitti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.