Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients

Launched by MONTECATONE REHABILITATION INSTITUTE S.P.A. · May 24, 2023

Keywords

ClinConnect Summary

**Summary of the Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injury Patients**

This clinical trial is studying how well a new robotic device called Hunova® can help improve trunk control in patients with spinal cord injuries (SCI). Trunk control is important because it affects how well a person can maintain their balance and posture, which is essential for everyday activities like sitting, standing, and moving. The trial will compare the effects of traditional rehabilitation alone to a combination of traditional rehab and training with the Hunova® device. Researchers hope to find out how many sessions with Hunova® are most beneficial for patients and measure changes in trunk control using both the device and a standard clinical scale.

To participate in this trial, individuals must have a spinal cord injury and meet specific criteria, such as being able to sit for at least one hour continuously and having stable health conditions. Participants will receive tailored rehabilitation treatments and will help researchers understand the best ways to improve trunk control after an SCI. This study is currently looking for volunteers, so if you or someone you know might be interested, it could be a valuable opportunity to contribute to important research in spinal cord injury recovery.

Gender

ALL

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.