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)
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1
IRCCS INRCA Hospital
Ancona, Italy, 60131
2
IRCCS INRCA Hospital
Fermo, Italy