## Protocol Section
### Identification Module
**NCT ID:** NCT02923479

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CRMINAIL01
#### Organization
**Class:** OTHER
**Full Name:** Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
### Status Module
#### Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-04

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Start Date
**Date:** 2013-03

**Status Verified Date:** 2016-09

#### Study First Post Date
**Date:** 2016-10-04
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-28
**Study First Submit QC Date:** 2016-10-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Istituto Italiano di Tecnologia

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Ankle Fractures

**Keywords:**

- Rehabilitation

- Robotics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

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

**Intervention Names:**

- Device: Specific ankle rehabilitation by ARBOT device

- Other: General Rehabilitation

**Label:** Experimental: ARBOT Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- 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

**Label:** Control Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental: ARBOT Group

**Description:** 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.

**Name:** Specific ankle rehabilitation by ARBOT device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Group

- Experimental: ARBOT Group

**Description:** All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.

**Name:** General Rehabilitation

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Control Group

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

**Name:** Specific ankle rehabilitation performed by physiotherapist

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Control Group

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

**Name:** Specific ankle rehabilitation by Biodex System 3 dynamometer

**Type:** DEVICE

#### Intervention 5

**Arm Group Labels:**

- Control Group

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

**Name:** Specific ankle rehabilitation by ProKin PK254 platform

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Change of Dorsiflexion Range of Motion

**Time Frame:** At baseline and after 1, 2, 3 and 4 weeks intervention

**Measure:** Change of Isometric peak torque at 0° and 10° of plantar flexion

**Time Frame:** At baseline and after 2 and 4 weeks intervention

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

**Time Frame:** At baseline and after 2 and 4 weeks intervention

**Measure:** Change of 2 Minute Walk Test (2MWT)

**Time Frame:** At baseline and after 2 and 4 weeks intervention

**Measure:** Side Effects using ARBOT

**Time Frame:** Through study completion, up to 4 weeks

#### Secondary Outcomes

**Measure:** Timed Stair Climbing Test (10 steps)

**Time Frame:** At baseline and after 2 and 4 weeks intervention

**Measure:** Proprioceptive tests (time taking and accuracy)

**Time Frame:** At baseline and after after 2 and 4 weeks intervention

**Measure:** Pain (VAS 0-10)

**Time Frame:** At baseline and after 1, 2, 3 and 4 weeks intervention

**Measure:** LEFS - The Lower Extremity Functional Scale

**Time Frame:** At baseline and after after 4 weeks intervention

**Measure:** AOFAS - Ankle-Hindfoot Scale

**Time Frame:** At baseline and after 4 weeks intervention

**Measure:** Patient Satisfaction (VAS 0-10)

**Time Frame:** After 4 weeks intervention

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Volterra

**Country:** Italy

**Facility:** INAIL - Centro di Riabilitazione Motoria di Volterra

**State:** Pisa

**Zip:** 56048

#### Overall Officials

**Official 1:**

**Affiliation:** INAIL - Centro di Riabilitazione Motoria di Volterra

**Name:** Paolo Catitti, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050723

- Term: Fractures, Bone

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000016512

- Term: Ankle Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M30291

- Name: Ankle Fractures

- Relevance: HIGH

- As Found: Ankle Fractures

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M18909

- Name: Ankle Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000064386

- Term: Ankle Fractures

### Misc Info Module

- Version Holder: 2024-05-24
