NCT04087083

Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation

Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of robotic device, in order to obtain the beneficial effects of this treatment.

Detailed description

Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke and improve walking function is often a key component of any rehabilitation program. To achieve this goal, robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects. In this single blind randomized controlled trial the investigators will include 150 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, acceptance of the technology, will be carried.

Conditions

• Stroke
• Aging Problems
• Innovative Rehabilitation Treatment Based on Robotics

Interventions

Type	Name	Description
OTHER	Technological intervention arm	Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training (G-EO system, Reha Technology, Switzerland), an end-effector technology that simulates floor walking and stairs climbing (up and down)
OTHER	Control arm	Each session will include 50 minutes of traditional physical rehabilitation therapy

Timeline

• Start date: 2021-02-15
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2019-09-12
• Last updated: 2023-10-23

Locations

2 sites across 1 country: Italy