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

Not Applicable

Completed

• Conditions: Ankle Fractures
• Interventions: 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

• Registration Number: NCT02923479
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-10-01
• Last Update Submitted: 2016-10-01
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Specific ankle rehabilitation by ProKin PK254 platform	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.
Experimental: ARBOT Group	Specific ankle rehabilitation by ARBOT device	The patients in the "ARBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific ankle rehabilitation by ARBOT device
Experimental: ARBOT Group	General Rehabilitation	The patients in the "ARBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific ankle rehabilitation by ARBOT device
Control Group	General Rehabilitation	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.
Control Group	Specific ankle rehabilitation performed by physiotherapist	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.
Control Group	Specific ankle rehabilitation by Biodex System 3 dynamometer	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Patient Satisfaction (VAS 0-10)	After 4 weeks intervention

Trial Locations

Locations (1)

INAIL - Centro di Riabilitazione Motoria di Volterra; 🇮🇹 Volterra, Pisa, Italy