The Role of SAtivex® in Robotic-Rehabilitation

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 28, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

June 30, 2018

Conditions
Rehabilitation
Interventions
DEVICE

Lokomat training

The neurorobotic treatment will be performed by using the Lokomat (Lokomat, Hocoma, Volketswil, Switzerland) device. The work load will be progressively adjusted based on the improvement of motor performances. Training parameters (weight support, etc) will be individually adapted. During the first Lokomat session, support will be set at 50% of the body weight and will be adapted on observation of the gait. The Lokomat motor guidance system will be first set at 100%, corresponding to a passive walk.

DRUG

Sativex

"Patients in treatment with Sativex will receive cannabis-based medicine extract presented in a pump action sublingual spray. Sativex is composed of whole cannabis plant extract, containing THC (27 mg/mL) and CBD (25 mg/mL), in ethanol/propylene glycol (50:50) excipient.~Each actuation delivers 100 KL of spray, containing THC 2.7 mg and CBD 2.5 mg. The number and frequency of dosing (sprays) with Sativex will vary from individual to individual and it may take a number of weeks to find the correct dose of Sativex for the individual patient."

Trial Locations (1)

98123

"IRCCS Centro Neurolesi Bonino-Pulejo", Messina

All Listed Sponsors
lead

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

NCT03186664 - The Role of SAtivex® in Robotic-Rehabilitation | Biotech Hunter | Biotech Hunter