Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
Spinal Cord Injury
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Robotic rehabilitation, Trunk control, Hunova
Eligibility Criteria
Inclusion Criteria: Spinal Cord Injury of any etiology; American Spinal Injury (AIS) grade A or B and American Spinal Injury Association (ASIA) neurological level T1 or below; alternatively AIS grade C or D and ASIA neurological level C4 or below; stable clinical conditions; maximum distance from the SCI event: 6 months; ability to maintain a sitting position for at least 1h continuously; subjects capable and collaborating, able to give in person their informed consent. Exclusion Criteria: wearer of tracheal cannula, with the need for bronchoaspiration; wearer of spine orthosis; instability or significant deformity of the spine and/or of the lower limbs; presence of paraosteoarthropathy (POA) in development/inflammatory phase; presence of ischial Pressure Lesion (PL) of stage ≥ 3, according to the National Pressure Ulcer Advisory Panel / European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification; need for a lifter for patient transfer; body weight ≥ 150 kg.
Sites / Locations
- Montecatone Rehabilitation Institute S.p.A.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Standard rehab plus 20-session Hunova rehabilitation
Standard rehab plus 10-session, delayed, Hunova rehabilitation
Patients will receive the Standard rehabilitation for a period of 4 weeks. In the same 4 weeks and days, the Hunova® rehabilitation (20 sessions in total) will also be administered.
Patients will receive the Standard rehabilitation for a period of 4 weeks. During the last 2 weeks, in the same days, the Hunova® rehabilitation (10 sessions in total) will be also administered.