Ankle FracturesNCT02923479
Robot-assisted Rehabilitation of Ankle Fractures: Efficacy and Comparison With Traditional Methods
A study testing Specific ankle rehabilitation by ARBOT device, General Rehabilitation and Specific ankle rehabilitation performed by physiotherapist in people with Ankle Fractures, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Specific ankle rehabilitation by ARBOT device, General Rehabilitation and Specific ankle rehabilitation performed by physiotherapist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Post-immobilization phase;
- Time interval since fracture event of less than 12 months;
- Signed informed consent acquisition.
Who cannot join
- Non-compliance with study requirements;
- Pregnancy or breast feeding;
- Current or prior history of malignancy;
- Open skin at the level of the patient-device interface;
- Sensory deficit at the level of the patient-device interface;
- Ankle motor deficit secondary to peroneal or tibial neuropathy;
- Acute inflammatory arthritis of the ankle;
- Other pathological conditions inducing lower limb pain or disfunction.
Trial locations and contacts
1 site in 1 country.
Italy1 site
INAIL - Centro di Riabilitazione Motoria di Volterra
Volterra, Pisa, 56048
About this study
Official title: Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
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.
Read the 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
- Being tested
- Specific ankle rehabilitation by ARBOT device, General Rehabilitation, Specific ankle rehabilitation performed by physiotherapist, Specific ankle rehabilitation by Biodex System 3 dynamometer, Specific ankle rehabilitation by ProKin PK254 platform
- Keywords
- Rehabilitation, Robotics
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific ankle rehabilitation by ARBOT deviceDevice
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 RehabilitationOther
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 physiotherapistOther
Subjects in the control group underwent manually assisted range of motion exercises.
Specific ankle rehabilitation by Biodex System 3 dynamometerDevice
Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer
Specific ankle rehabilitation by ProKin PK254 platformDevice
Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ARBOT Group | Experimental | The patients in the "ARBOT Group" underwent to following interventions:
1. General Rehabilitation
2. Specific ankle rehabilitation by ARBOT device Receives: Device: Specific ankle rehabilitation by ARBOT device; Other: General Rehabilitation |
| Control Group | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Dorsiflexion Range of Motion
Measured: At baseline and after 1, 2, 3 and 4 weeks intervention
Change of Isometric peak torque at 0° and 10° of plantar flexion
Measured: At baseline and after 2 and 4 weeks intervention
Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec
Measured: At baseline and after 2 and 4 weeks intervention
Change of 2 Minute Walk Test (2MWT)
Measured: At baseline and after 2 and 4 weeks intervention
Side Effects using ARBOT
Measured: Through study completion, up to 4 weeks
Secondary outcomes (6)
Timed Stair Climbing Test (10 steps)
Measured: At baseline and after 2 and 4 weeks intervention
Proprioceptive tests (time taking and accuracy)
Measured: At baseline and after after 2 and 4 weeks intervention
Pain (VAS 0-10)
Measured: At baseline and after 1, 2, 3 and 4 weeks intervention
LEFS - The Lower Extremity Functional Scale
Measured: At baseline and after after 4 weeks intervention
AOFAS - Ankle-Hindfoot Scale
Measured: At baseline and after 4 weeks intervention
Patient Satisfaction (VAS 0-10)
Measured: After 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Responsible party
- Sponsor
- Investigators
- Paolo Catitti, MD, Principal investigator, INAIL - Centro di Riabilitazione Motoria di Volterra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923479
- Sponsor's protocol ID
- CRMINAIL01
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02923479
- Acronym / sponsor ID
- CRMINAIL01
- Conditions
- Ankle Fractures
- Keywords
- Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: ARBOT Group | Experimental | Device: Specific ankle rehabilitation by ARBOT device, Other: General RehabilitationThe patients in the "ARBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific ankle rehabilitation by ARBOT device |
| Control Group | Other | 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 platformThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Functional limitation following work-related ankle injuries, including:
- Post-immobilization phase;
- Time interval since fracture event of less than 12 months;
- Signed informed consent acquisition.
Key exclusion criteria (8 listed)
- Non-compliance with study requirements;
- Pregnancy or breast feeding;
- Current or prior history of malignancy;
- Open skin at the level of the patient-device interface;
- Sensory deficit at the level of the patient-device interface;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific ankle rehabilitation by ARBOT deviceARBOT 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. | Device | Experimental: ARBOT Group |
| General RehabilitationAll patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program. | Other | Control Group, Experimental: ARBOT Group |
| Specific ankle rehabilitation performed by physiotherapistSubjects in the control group underwent manually assisted range of motion exercises. | Other | Control Group |
| Specific ankle rehabilitation by Biodex System 3 dynamometerSubjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer | Device | Control Group |
| Specific ankle rehabilitation by ProKin PK254 platformSubjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform. | Device | Control Group |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- BackgroundSaglia 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.
- BackgroundSaglia 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.
- BackgroundSaglia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Catitti, MD principal investigator
INAIL - Centro di Riabilitazione Motoria di Volterra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific ankle rehabilitation by ARBOT device, General Rehabilitation and Specific ankle rehabilitation performed by physiotherapist in people with Ankle Fractures, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Dorsiflexion Range of Motion (time frame: At baseline and after 1, 2, 3 and 4 weeks intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923479, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.