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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923479
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Istituto Italiano di Tecnologia
Information provided by (Responsible Party):
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Tracking Information
First Submitted Date  ICMJE September 28, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2016)
  • Change of Dorsiflexion Range of Motion [ Time Frame: At baseline and after 1, 2, 3 and 4 weeks intervention ]
  • Change of Isometric peak torque at 0° and 10° of plantar flexion [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  • Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  • Change of 2 Minute Walk Test (2MWT) [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  • Side Effects using ARBOT [ Time Frame: Through study completion, up to 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2016)
  • Timed Stair Climbing Test (10 steps) [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  • Proprioceptive tests (time taking and accuracy) [ Time Frame: At baseline and after after 2 and 4 weeks intervention ]
  • Pain (VAS 0-10) [ Time Frame: At baseline and after 1, 2, 3 and 4 weeks intervention ]
  • LEFS - The Lower Extremity Functional Scale [ Time Frame: At baseline and after after 4 weeks intervention ]
  • AOFAS - Ankle-Hindfoot Scale [ Time Frame: At baseline and after 4 weeks intervention ]
  • Patient Satisfaction (VAS 0-10) [ Time Frame: After 4 weeks intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot-assisted Rehabilitation of Ankle Fractures: Efficacy and Comparison With Traditional Methods
Official Title  ICMJE Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ankle Fractures
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental: ARBOT Group

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

    1. General Rehabilitation
    2. Specific ankle rehabilitation by ARBOT device
    Interventions:
    • Device: Specific ankle rehabilitation by ARBOT device
    • Other: General Rehabilitation
  • 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.
    Interventions:
    • Other: General Rehabilitation
    • Other: Specific ankle rehabilitation performed by physiotherapist
    • Device: Specific ankle rehabilitation by Biodex System 3 dynamometer
    • Device: Specific ankle rehabilitation by ProKin PK254 platform
Publications *
  • 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. 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. Inverse-Kinematics-Based Control of a Redundantly Actuated Platform for Rehabilitation. Journal of Systems and Control Engineering, IMechE Proceedings 2009; 223 (1): 53-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2016)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923479
Other Study ID Numbers  ICMJE CRMINAIL01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Study Sponsor  ICMJE Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborators  ICMJE Istituto Italiano di Tecnologia
Investigators  ICMJE
Principal Investigator: Paolo Catitti, MD INAIL - Centro di Riabilitazione Motoria di Volterra
PRS Account Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP