A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• age between 18 and 85 years;

• first stroke with neurological outcomes affecting the upper limb;

• patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 \<FM-UL ≤ 44) motor deficit;

• patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI\> 30);

• Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3;

• sufficient cognitive and linguistic level to understand the instructions and provide consent;

• signed informed consent.

Locations
Other Locations
Italy
HABILITA S.p.A
WITHDRAWN
Bergamo
Villa Bellombra
COMPLETED
Bologna
Azienda Ospedaliero-Universitaria di Ferrara
COMPLETED
Ferrara
Azienda Ospedaliero Universitaria Ospedali Riuniti
COMPLETED
Foggia
IRCCS Centro Neurolesi Bonino Pulejo
COMPLETED
Messina
IRCCS San Raffaele Pisana
RECRUITING
Roma
IRCCS fondazione Santa Lucia
COMPLETED
Rome
Fondazione Gli Angeli di Padre Pio
COMPLETED
San Giovanni Rotondo
Contact Information
Primary
Sanaz Pournajaf, Dr.
sanaz.pournajaf@sanraffaele.it
+39-065225
Backup
Michela Goffredo, Ing.
michela.goffredo@sanraffaele.it
Time Frame
Start Date: 2020-12-28
Estimated Completion Date: 2025-12-24
Participants
Target number of participants: 70
Treatments
Experimental: Experimental Group (EG)
The experimental group (EG), in addition to the standard treatment, will perform one session per day, each lasting 40 minutes, with the Armeo Power robotic system for upper limb rehabilitation. Each subject will perform a total of 25 ± 3 treatment sessions with a frequency of 5 times a week for 5 weeks.
Active_comparator: Control Group (CG)
The control group (CG), in addition to the standard routine rehabilitation treatment, will follow 40 minutes of conventional upper limb rehabilitation. Each subject will perform a total of 25 ± 3 conventional upper limb treatment sessions with a frequency of 5 times a week for 5 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Presidio Ospedaliero Accreditato Villa Bellombra S.p.A, Fondazione Gli Angeli di Padre Pio, IRCCS Centro Neurolesi Bonino Pulejo, I.R.C.C.S. Fondazione Santa Lucia, Università degli Studi di Ferrara, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Ministry of Health, Italy
Leads: IRCCS San Raffaele Roma

This content was sourced from clinicaltrials.gov