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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

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.

Condition or disease Intervention/treatment Phase
Ankle Fractures Device: Specific ankle rehabilitation by ARBOT device 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
Study Start Date : March 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: ARBOT Group

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

  1. General Rehabilitation
  2. Specific ankle rehabilitation by ARBOT device
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.

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.
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.




Primary Outcome Measures :
  1. Change of Dorsiflexion Range of Motion [ Time Frame: At baseline and after 1, 2, 3 and 4 weeks intervention ]
  2. Change of Isometric peak torque at 0° and 10° of plantar flexion [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  3. Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  4. Change of 2 Minute Walk Test (2MWT) [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  5. Side Effects using ARBOT [ Time Frame: Through study completion, up to 4 weeks ]

Secondary Outcome Measures :
  1. Timed Stair Climbing Test (10 steps) [ Time Frame: At baseline and after 2 and 4 weeks intervention ]
  2. Proprioceptive tests (time taking and accuracy) [ Time Frame: At baseline and after after 2 and 4 weeks intervention ]
  3. Pain (VAS 0-10) [ Time Frame: At baseline and after 1, 2, 3 and 4 weeks intervention ]
  4. LEFS - The Lower Extremity Functional Scale [ Time Frame: At baseline and after after 4 weeks intervention ]
  5. AOFAS - Ankle-Hindfoot Scale [ Time Frame: At baseline and after 4 weeks intervention ]
  6. Patient Satisfaction (VAS 0-10) [ Time Frame: After 4 weeks intervention ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923479


Locations
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Italy
INAIL - Centro di Riabilitazione Motoria di Volterra
Volterra, Pisa, Italy, 56048
Sponsors and Collaborators
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Istituto Italiano di Tecnologia
Investigators
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Principal Investigator: Paolo Catitti, MD INAIL - Centro di Riabilitazione Motoria di Volterra
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.

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Responsible Party: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
ClinicalTrials.gov Identifier: NCT02923479    
Other Study ID Numbers: CRMINAIL01
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro:
Rehabilitation
Robotics
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries