Improving trunk control in spinal cord injury patients using robotic rehabilitation

Efficacy of Combined Treatment With Hunova® Instrumentation and Standard Rehabilitation, Compared to Standard Rehabilitation, on the Improvement of Trunk Control in Spinal Cord Injured Patients: Hunova® Randomized Controlled Trial

This study is testing if using a robotic device can help people with spinal cord injuries improve their trunk control better than regular rehab methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montecatone Rehabilitation Institute S.p.A. (other)
• Locations: 1 site (Imola, BO)
• Trial ID: NCT05887752 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Hunova® robotic rehabilitation device in improving trunk control among patients with spinal cord injuries (SCI). The study compares standard rehabilitation methods with those supplemented by robotic training to assess improvements in postural control, balance, and proprioception. Participants will undergo evaluations using objective tools to measure their trunk control and muscle activation patterns. The goal is to establish a more effective rehabilitation approach for SCI patients, addressing a significant gap in current treatment methodologies.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with spinal cord injuries classified as AIS grade A, B, C, or D, who are within six months of their injury and can maintain a sitting position for at least one hour.

Not a fit: Patients with severe spinal deformities, significant pressure lesions, or those requiring extensive assistance for transfers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to enhanced rehabilitation strategies that significantly improve daily functioning and quality of life for spinal cord injury patients.

How similar studies have performed: While several studies have shown success in using robotic rehabilitation for stroke patients, evidence for its effectiveness in spinal cord injury patients is limited, making this approach relatively novel.

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.

Where this trial is running

Imola, BO

• Montecatone Rehabilitation Institute S.p.A. — Imola, BO, Italy (RECRUITING)

Study contacts

• Principal investigator: Ilaria Baroncini, MD — Montecatone Rehabilitation Institute S.p.A.
• Study coordinator: Ilaria Baroncini, MD

Conditions: Spinal Cord Injury, Robotic rehabilitation, Trunk control, Hunova