Status:

UNKNOWN

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

Lead Sponsor:

Istituto Nazionale di Ricovero e Cura per Anziani

Conditions:

Stroke

Aging Problems

Eligibility:

All Genders

65+ years

Phase:

NA

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 orde...

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 ra...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 30 2024

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT04087083

Start Date

February 15 2021

End Date

March 30 2024

Last Update

October 23 2023

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

IRCCS INRCA Hospital

Ancona, Italy, 60131

2

IRCCS INRCA Hospital

Fermo, Italy