Status:
COMPLETED
Stroke Rehabilitation With Exoskeleton-assisted Gait.
Lead Sponsor:
IRCCS San Raffaele Roma
Collaborating Sponsors:
Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso
Fondazione Centri di Riabilitazione Padre Pio Onlus
Conditions:
Severe Stroke
Acute Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported...
Detailed Description
\*Procedures During Screening Process: This multicentric study will involve recruitment of individuals who have experienced a middle to severe stroke as well as patients with similar neurological wea...
Eligibility Criteria
Inclusion
- stroke or similar neurological pathologies:
- 2 weeks up to 6 months after the acute event (subacute patients);
- 6 months or more after the acute event (chronic patients)
- age between 18-80 years;
- ability to fit into the device and joint motion which allows gait with it;
- ability to tolerate upright standing for 30 seconds even with upper limbs support;
- sufficient upper extremity strength and balance which allow gait with device;
- ability and willing to give written consent and comply with the study procedures, including the follow-up visits.
Exclusion
- subject's height shorter than 150 cm or taller than 190 cm;
- subject's weight greater than 100 kg;
- contractures of the hip, knee, or ankle joints that might limit normal Range of Motion during gait;
- medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
- history of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device;
- cognitive and/or communicative disability (e.g. due to brain injury): patients must be able to follow directions and demonstrate learning skills;
- pregnancy ;
- untreated Deep Vein Thrombosis (DVT).
Key Trial Info
Start Date :
March 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03395717
Start Date
March 16 2016
End Date
March 30 2020
Last Update
April 10 2024
Active Locations (4)
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1
Villa Beretta
Costa Masnaga, Italy
2
Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Trevi
Foligno, Italy
3
IRCCS San Raffaele Pisana
Roma, Italy, I-00163
4
Fondazione Centri di Riabilitazione Padre Pio Onlus
San Giovanni Rotondo, Italy