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

NCT04087083 | Unknown

• 1 other identifier: INRCA-01-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Aging Problems; Innovative Rehabilitation Treatment Based on Robotics

Keywords

stroke; robotic rehabilitation; frail elderly; gait performance; balance; risk of falling; quality of life

Outcome Measures

Primary Outcomes (1)

• difference in falling risk between experimental arm and control arm

  falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). Balance section of Tinetti Performance Oriented Mobility Assessment (Tinetti Performance Oriented Mobility Assessment has two subscales, Balance and Gait section.) Balance section has 9 items. Each item can be scored in a 3 point ordinal scale (0-2). "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 16. Total score is obtained by adding the individual scores.

  before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention

Secondary Outcomes (3)

• difference in gait performance between experimental arm and control arm

  before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention

• difference in fear of falling between experimental arm and control arm

  before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention

• difference in quality of life between experimental arm and control arm: SF-12 health survey

  before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention

Study Arms (2)

technological intervention arm

EXPERIMENTAL

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

Other: Technological intervention arm

Control arm

ACTIVE COMPARATOR

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

Other: Control arm

Interventions

Technological intervention arm 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)

technological intervention arm

Control arm OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

Control arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (2)

IRCCS INRCA Hospital

Ancona, 60131, Italy

RECRUITING

IRCCS INRCA Hospital

Fermo, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 34127032 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Roberta Bevilacqua

CONTACT

00390718004767; r.bevilacqua@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: February 15, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)