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

NCT ID: NCT04087083

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2024-03-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

technological intervention arm

Twenty technological treatment sessions divided into 3 training sessions per week for 7 weeks.

Group Type: EXPERIMENTAL

Technological intervention arm

Intervention Type: OTHER

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)

Control arm

Twenty traditional treatment sessions divided into 3 training sessions per week for 7 weeks.

Group Type: ACTIVE_COMPARATOR

Control arm

Intervention Type: OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

Interventions

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)

Intervention Type: OTHER

Control arm

Each session will include 50 minutes of traditional physical rehabilitation therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Capacity to consent
• Ischemic or hemorrhagic stroke within 3 months to the recruitment, proven by computerized axial tomography or nuclear magnetic resonance
• Functional Ambulation Category (FAC) score ≤ 2
• Ranking scale score ≤ 3
• Complete communication and comprehension skills, assessed during the objective examination
• Ability to stand upright, supported or unsupported, for 1 minute

Exclusion Criteria

• Concomitant participation in other studies
• Severe hypertonus of the hip, knee, ankle of the paretic leg with a modified Ashworth scale score ≥3
• Severe hip, knee or ankle contracture or orthopedic problem affecting ambulation that would preclude passive range of motion of the paretic leg
• Deep vein thrombosis of the lower limbs
• Other cognitive, motor and sensory deficits that negatively condition robotic training
• Treatment of spasticity of the lower limb within 3 months to the start of the study or during the study
• Lack of written informed consent
• Clinical dementia rating (CDR) score ≥ 3
• Severe systemic diseases with life expectancy < 1 year

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: RECRUITING

IRCCS INRCA Hospital

Fermo, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Roberta Bevilacqua

Role: CONTACT

r.bevilacqua@inrca.it

00390718004767

Facility Contacts

Elvira Maranesi

Role: primary

e.maranesi@inrca.it

Valentina Di Donna

Role: primary

v.didonna@inrca.it

References

Maranesi E, Bevilacqua R, Di Rosa M, Pelliccioni G, Di Donna V, Luzi R, Morettini M, Sbrollini A, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Burattini L, Riccardi GR. An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial. Trials. 2021 Jun 14;22(1):400. doi: 10.1186/s13063-021-05357-8.

Reference Type: DERIVED

PMID: 34127032 (View on PubMed)

Other Identifiers

INRCA-01-2019

Identifier Type: -

Identifier Source: org_study_id