Robot-assisted Ankle Rehabilitation Using the High-performance Robotic Device IIT-ARBOT: A Pilot Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change of Dorsiflexion Range of Motion
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of Dorsiflexion Range of Motion
时间窗: At baseline and after 1, 2, 3 and 4 weeks intervention
Change of Isometric peak torque at 0° and 10° of plantar flexion
时间窗: At baseline and after 2 and 4 weeks intervention
Change of Isokinetic plantar-flexion torque at speed of 30°, 60°, 120°/sec
时间窗: At baseline and after 2 and 4 weeks intervention
Change of 2 Minute Walk Test (2MWT)
时间窗: At baseline and after 2 and 4 weeks intervention
Side Effects using ARBOT
时间窗: Through study completion, up to 4 weeks
次要结局
- 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)