NCT02923479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

October 4, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

September 28, 2016

Last Update Submit

October 1, 2016

Conditions

Ankle Fractures

Keywords

RehabilitationRobotics

Outcome Measures

Primary Outcomes (5)

  • Change of Dorsiflexion Range of Motion

    At baseline and after 1, 2, 3 and 4 weeks intervention

  • Change of Isometric peak torque at 0° and 10° of plantar flexion

    At baseline and after 2 and 4 weeks intervention

  • Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec

    At baseline and after 2 and 4 weeks intervention

  • Change of 2 Minute Walk Test (2MWT)

    At baseline and after 2 and 4 weeks intervention

  • Side Effects using ARBOT

    Through study completion, up to 4 weeks

Secondary Outcomes (6)

  • Timed Stair Climbing Test (10 steps)

    At baseline and after 2 and 4 weeks intervention

  • Proprioceptive tests (time taking and accuracy)

    At baseline and after after 2 and 4 weeks intervention

  • Pain (VAS 0-10)

    At baseline and after 1, 2, 3 and 4 weeks intervention

  • LEFS - The Lower Extremity Functional Scale

    At baseline and after after 4 weeks intervention

  • AOFAS - Ankle-Hindfoot Scale

    At baseline and after 4 weeks intervention

  • +1 more secondary outcomes

Study Arms (2)

Experimental: ARBOT Group

EXPERIMENTAL

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 deviceOther: 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.

Other: General RehabilitationOther: Specific ankle rehabilitation performed by physiotherapistDevice: Specific ankle rehabilitation by Biodex System 3 dynamometerDevice: Specific ankle rehabilitation by ProKin PK254 platform

Interventions

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.

Experimental: ARBOT Group
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.

Control GroupExperimental: ARBOT Group
Specific ankle rehabilitation performed by physiotherapistOTHER

Subjects in the control group underwent manually assisted range of motion exercises.

Control Group
Specific ankle rehabilitation by Biodex System 3 dynamometerDEVICE

Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer

Control Group
Specific ankle rehabilitation by ProKin PK254 platformDEVICE

Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INAIL - Centro di Riabilitazione Motoria di Volterra

Volterra, Pisa, 56048, Italy

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Paolo Catitti, MD

    INAIL - Centro di Riabilitazione Motoria di Volterra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 4, 2016

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 4, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)